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Recalls affecting Minnesota

Data last updated: September 9, 2026 at 1:18 PM UTC

16,909 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 22, 2020

smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.

A manufacturing error resulted in not meeting quality requirements R3 Acetabular Shells

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85637
Lot/product code:
71338733, Lot Numbers: 19DM28110, 19DM28106, 19DM28106A  71338734, Lot Numbers: 19DM28114  71338735, Lot Numbers: 19DM28116  71338736, Lot Numbers: 19EM19673, 19EM19683, 19EM19678  71338737, Lot Numbers: 18JM12872  71338738, Lot Numbers: 18FM02387  71338740, Lot Numbers: 18JM02713  71338741, Lot Numbers: 19AM22770, 19AM22770A
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 22, 2020

smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.

A manufacturing error resulted in not meeting quality requirements R3 Acetabular Shells

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85637
Lot/product code:
71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572   71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19AM15809, 19AM15828, 19AM15829   71331850, Lot Numbers: 18LM00667, 18LM00668, 18LM00670, 18LM00671, 18LM00702, 18LM00668A, 18LM00671A    71331852, Lot Numbers: 19EM10292, 18KM20315, 18KM15739, 18KM20284, 18LM17941, 18LM02317, 18KM00744, 18KM00775, 18KM00779, 18KM00833, 18KM06667, 18KM06675, 18KM06676, 18KM06680, 18KM06681, 18KM06682, 18KM13594, 18KM13632, 18KM15736, 18KM15737, 18KM15738, 18KM20281, 18KM20289, 18KM20291, 18KM20292, 18KM24785, 18KM24792, 18KM24795, 18KM24805, 18LM02315, 18LM02337, 18LM17942, 18LM17946, 18KM20281A, 18LM07653, 18KM15736A, 18LM14077, 18KM24785A, 18KM20293A  71331854, Lot Numbers: 18JM13875, 18mm08723, 18JM13874, 19AM17866, 19AM17869, 18GM07436, 18GM07437, 18GM07438, 18GM07445, 18GM07469, 18GM07522, 18GM07533, 18KM03144, 18KM03147, 18KM03148, 18KM23654, 18KM23655, 18KM23662, 18MM08650, 18MM08663, 18MM08676, 18MM08678, 18MM08683, 18MM08695, 18MM08697, 18MM08724, 19AM17823, 19AM17833, 19AM17837, 19AM17845, 18MM08650A, 18MM08663A, 19AM17845A, 19AM17833A, 19AM17837A  71331856, Lot Numbers: 18JM15947, 18MM12475, 18JM15950, 18KM04251, 18HM19101, 18JM15940, 18KM04254, 18HM19123, 18KM15773, 18JM15949, 18JM15949A, 18LM18546, 18HM19116, 18HM19117, 18JM15941, 18KM04226, 18KM04250, 18KM04252, 18KM04253, 18KM13646, 18KM17025, 18KM17026, 18KM17029, 18KM17031, 18KM17032, 18LM18544, 18LM18550, 18MM12424, 18MM12426, 18MM12428, 18MM15587, 18MM15611, 18LM05390, 18KM17031A, 18LM18550A    71331858, Lot Numbers: 19AM03504, 19AM03511   71331860, Lot Numbers: 18JM10154, 18JM10154A
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 22, 2020

smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 71331968 Orthopedic implant component.

A manufacturing error resulted in not meeting quality requirements R3 Acetabular Shells

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85637
Lot/product code:
71331942, Lot Numbers: 18HM20692, 18EM07919  71331946, Lot Numbers: 18GM07650, 18GM18522, 18JM01361, 18JM14484, 19DM17868, 19DM17872, 19EM20020, 18GM18521, 18JM14573, 19DM10929, 19DM10931, 19DM17866, 19DM17869, 19DM17871, 19EM20018  71331948, Lot Numbers: 18GM16878, 18JM08597, 18JM08598, 18JM08599, 18JM08600, 18MM01816, 18MM01825, 19BM08346, 19BM08353, 19BM08377, 19BM21631, 19BM21634, 19BM21642, 19CM00707, 19CM00729, 19DM17874, 19DM17875, 19DM17879, 19EM05719, 19EM05725, 19EM05727, 19EM05734, 19EM05735, 19EM05739, 19EM11935, 19EM19991, 19EM19995, 18GM16862, 19BM21637, 18GM16845, 18GM16860, 18GM16874, 18JM18993, 18DM20332, 18LM03848, 18MM01811, 18MM01818, 18LM03812, 18LM03851, 19BM08371, 19BM08373, 19BM21639, 19BM21643, 19CM00735, 19DM10935, 19DM17873, 19DM17878, 19EM11942, 19EM11943, 18LM17674, 19EM05738, 18GM04745, 18GM04750  71331950, Lot Numbers: 18FM17581, 18HM16477, 18HM16477A, 18HM16490, 18JM12754, 18JM12755, 18JM12814, 18KM08903, 18KM08903A, 18LM02612, 18LM02630, 19BM12905, 19CM15757, 19CM15761, 19CM15763, 19CM15765, 19DM06283, 19DM06289, 19DM06292, 19DM06486, 19DM10837, 19DM10842, 19DM10846, 19DM10851, 19EM11937, 19EM23519, 18FM17575, 18FM17585, 18GM01198, 18GM01198A, 18GM01210, 18GM01210A, 18GM04645, 18EM19483, 18EM19487, 18EM19523, 18GM01189, 18GM04664, 18HM16471, 18JM05420, 18JM12752, 18LM02613, 18LM11113, 19AM02040, 19AM02041, 19AM07778, 19CM01534, 19CM01543, 19CM15767, 19DM10838, 19DM10840, 19DM21848, 19EM11934, 19EM23498, 18EM19487A, 18GM01189A, 19CM15767A  71331952, Lot Numbers: 18FM02425, 18FM02426, 18FM02564, 18FM07528, 18GM00538, 18GM00538A, 18GM00584, 18GM00584A, 18GM09578, 18GM16948, 18HM23446, 18HM23446B, 18KM06737, 18KM26471, 18KM26480, 18LM02644, 18LM10385, 18LM13667, 18LM13690, 18LM13690A, 18LM18647, 18MM02055, 18MM02057, 18MM05762, 18MM05762A, 18MM05765, 18MM05765A, 19BM20198, 19BM20220, 19BM20220A, 19BM22774, 19BM22783, 19BM22788, 19CM22628, 19CM22632, 19CM22636, 19DM21882, 19DM21888, 19DM21905, 19DM21909, 19DM21914, 19EM05796, 19EM05808, 19EM17709, 18MM02039, 19BM20216, 19EM05799, 19BM20216A, 18FM11963, 18FM11965, 18FM11967, 18FM14864, 18FM14867, 18FM14868, 18GM00592, 18GM06508, 18GM06508A, 18GM06515, 18GM06533, 18GM06538, 18GM06541, 18GM06541A, 18GM06550, 18GM06555, 18EM13854, 18EM13857, 18FM02427, 18GM00587, 18GM07654, 18GM07666, 18HM23462, 18JM12782, 18JM12786, 18KM26470, 18LM02631, 18LM02666, 18LM13681, 18MM05787, 18MM05761, 18MM14820, 19AM02947, 19BM22771, 19DM21896, 19DM21899, 19DM21901, 19DM21904, 19DM21913, 19EM05797, 19EM05807, 19EM17702, 19EM17711, 18EM13857A, 18JM17200, 18JM07185, 18KM26470A, 18MM05761A, 19EM17702A, 18KM06740, 18KM06742  71331954, Lot Numbers: 18FM02432, 18FM02432B, 18FM02434, 18FM02434A, 18GM16959, 18GM16960, 18HM15320, 18HM15321, 18HM15321A, 18HM15321B, 18JM19411, 18LM02200, 18LM02228, 18LM02230, 18LM02255, 18LM10395, 19BM06530, 19BM06543, 19BM06623, 19BM06638, 19BM15988, 19BM16038, 19BM16039, 19BM16041, 19BM16043, 19BM16046, 19BM16048, 19BM20215, 19BM20222, 19BM20225, 19BM20227, 19BM20229, 19CM03984, 19CM04027, 19CM04033, 19CM04040, 19CM04045, 19CM04076, 19CM07039, 19CM07047, 19CM07054, 19CM07055, 19CM07055A, 19CM07056, 19CM07064, 19CM13919, 19CM19644, 19CM24281, 19DM07241, 19DM07247, 19DM07281, 19EM17724, 19EM20003, 18FM00161, 18FM16470, 18FM16474, 18FM16474A, 18FM16474B, 18FM16499, 18FM16548, 18FM21531, 18FM21557, 18EM17276, 18EM19555, 18EM19576, 18EM19577, 18FM01943, 18FM21566, 18LM02198, 18LM02201, 18LM02234, 18LM10394, 19BM06588, 19BM06662, 19BM20209, 19BM20210, 19BM20214, 19CM04002, 19CM04039, 19CM04043, 19CM13954, 19DM07256, 19DM15693, 19EM17720, 19EM23472, 18FM10239, 18HM15322A, 19CM04002A, 19CM04043A, 19DM15692A, 18KM01915, 18KM01929, 18KM01915A  71331956, Lot Numbers: 18EM20519, 18EM20521, 18GM06721, 18GM07670, 18GM16963, 18GM16965, 18HM04576, 18HM04581, 18HM04584, 18HM16084, 18LM02244, 18MM07586, 19CM03364, 19CM03365, 19CM03379, 19CM17413, 19DM07296, 19DM07297, 19DM07302, 19DM15697, 19DM15704, 19DM15710, 19DM29305, 19DM29332, 19DM29332A, 19EM09555, 19EM09558, 19EM20026, 18EM20515, 18GM00126, 18GM00127, 18GM00131, 18GM06708, 18GM06734, 18GM17029, 18GM17029A, 18JM04042, 18EM18364, 18GM00125, 18LM03826, 18LM03836, 18LM18627, 18MM01835, 19CM17414, 19DM07294, 19DM15696, 19DM15700, 19DM15706, 19DM15707, 19DM29300, 19EM09543, 19EM09556, 18LM18627A, 19CM18371, 18KM01961, 18KM01961A, 18LM09318A  71331958, Lot Numbers: 18GM09602, 18HM15999, 18HM21285, 18HM21291, 18HM21291A, 18KM00268, 18KM00268A, 18LM17980, 18LM17981, 19BM07155, 19BM07167, 19BM07168, 19BM07168, 19BM07170, 19BM07186, 19BM22782, 19BM22785, 19BM22786, 19BM22787, 19CM11398, 19CM11400, 19CM11411, 19CM11412, 19CM11421, 19DM10942, 19DM10943, 19DM10945, 19EM11290, 19EM11291, 18KM00271, 18KM00272, 18KM00263, 19BM07191, 18KM00271A, 18KM00272A, 18FM09877, 18FM12880, 18FM02438, 19BM07171, 19BM07192, 19BM07195, 19BM22784, 19CM11388, 19CM11394, 19DM10947, 19DM10949, 19EM23518, 18FM02438B, 19EM23518A  71331960, Lot Numbers: 18GM06745, 19CM17416, 19DM12906, 19DM12911, 19DM12912, 18EM23148,… (truncated, 5296 characters total — see the official FDA record for the full value)
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2020

ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85590
Lot/product code:
MODEL: 1P31-25 LOT NUMBERS: 04281BE00, 08510BE00 and 11221BE00 Shelf life per LOT: 04281BE00;2020-MAY-21 08510BE00; 2020-AUG-08 11221BE00;2020-NOV-18
Recalling firm:
Abbott Gmbh & Co. KG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2020

MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. This data can be uploaded to a computer for analysis of historical glucose values.

Missing solder battery connection, which could interrupt power of insulin pump.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85711
Lot/product code:
All serial numbers expiration date- 3 years from date of manufacture.  NG2093124H NG2093129H NG2093154H NG2093164H NG2093187H NG2093188H NG2093193H NG2093219H NG2093228H NG2093235H NG2093253H NG2093254H NG2093257H NG2093258H NG2093265H NG2093269H NG2093288H NG2093303H NG2093307H NG2093345H NG2093349H NG2093362H NG2093377H NG2093397H NG2093423H NG2093425H NG2093426H NG2093463H NG2093466H NG2093476H NG2093478H NG2093521H NG2093558H NG2093564H NG2093577H NG2093608H NG2093624H NG2093670H NG2093673H NG2093675H NG2093693H NG2093697H NG2093707H NG2093708H NG2093711H NG2093712H NG2093734H NG2093743H NG2093764H NG2093777H NG2093825H NG2093835H NG2093844H NG2093860H NG2093869H NG2093871H NG2093889H NG2093891H NG2093894H NG2093922H NG2093932H NG2093969H NG2093973H NG2093981H NG2094026H NG2094030H NG2094035H NG2094043H NG2094044H NG2094048H NG2094053H NG2094075H NG2094082H NG2094231H NG2094234H NG2094235H NG2094237H NG2094239H NG2094241H NG2094242H NG2094245H NG2094248H NG2094249H NG2094250H NG2094254H NG2094256H NG2094258H NG2094259H NG2094262H NG2094263H NG2094266H NG2094272H NG2094274H NG2094276H NG2094281H NG2094282H NG2094286H NG2094288H NG2094289H NG2094290H NG2094292H NG2094294H NG2094295H NG2094297H NG2094302H NG2094303H NG2094304H NG2094306H NG2094307H NG2094313H NG2094315H NG2094322H NG2094326H NG2094329H NG2094330H NG2094338H NG2094341H NG2094342H NG2094344H NG2094347H NG2094349H NG2094351H NG2094352H NG2094355H NG2094358H NG2094360H NG2094362H NG2094363H NG2094364H NG2094366H NG2094368H NG2094376H NG2094380H NG2094382H NG2094389H NG2094390H NG2094393H NG2094398H NG2094401H NG2094402H NG2094403H NG2094406H NG2094408H NG2094419H NG2094424H NG2094428H NG2094430H NG2094433H NG2094434H NG2094444H NG2094447H NG2094450H NG2094454H NG2094458H NG2094460H NG2094461H NG2094464H NG2094466H NG2094470H NG2094471H NG2094477H NG2094479H NG2094485H NG2094489H NG2094490H NG2094493H NG2094496H NG2094497H NG2094499H NG2094509H NG2094517H NG2094519H NG2094527H NG2094528H NG2094529H NG2094533H NG2094534H NG2094536H NG2094537H NG2094555H NG2094585H NG2094594H NG2111643H -U.S.
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2020

MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, fourteen years of age and older, requiring insulin.

Missing solder battery connection, which could interrupt power of insulin pump.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85711
Lot/product code:
All serial numbers; expiration date- 3 years from date of manufacture.  NG2094617H NG2094618H NG2094623H NG2094625H NG2094627H NG2094628H NG2094629H NG2094631H NG2094632H NG2094634H NG2094635H NG2094636H NG2094637H NG2094638H NG2094639H NG2094640H NG2094641H NG2094642H NG2094644H NG2094645H NG2094646H NG2094647H NG2094648H NG2094649H NG2094650H NG2094651H NG2094652H NG2094653H NG2094654H NG2094655H NG2094656H NG2094657H NG2094658H NG2094659H NG2094660H NG2094661H NG2094662H NG2094663H NG2094664H NG2094668H NG2094669H NG2094670H NG2094695H NG2094696H NG2094697H NG2094698H NG2094699H NG2094700H NG2094702H NG2094704H NG2094705H NG2094707H NG2094711H NG2094712H NG2094714H NG2094718H NG2094719H NG2094724H NG2094726H NG2094728H NG2094730H NG2094732H NG2094733H NG2094735H NG2094737H NG2094739H NG2094740H NG2094743H NG2094767H NG2094769H NG2094771H NG2094772H NG2094773H NG2094774H NG2094775H NG2094776H NG2094777H NG2094779H NG2094781H NG2094783H NG2094789H NG2094795H NG2094799H NG2094800H NG2094801H NG2094803H NG2094805H NG2094806H NG2094807H NG2094809H NG2094820H NG2094822H NG2094824H NG2094825H NG2094826H NG2094827H NG2094828H NG2094829H NG2094830H NG2094832H NG2094834H NG2094836H NG2094846H NG2094847H NG2094849H NG2094851H NG2094853H NG2094855H NG2094856H NG2094858H NG2094860H NG2094862H NG2094863H NG2094864H NG2094865H NG2094866H NG2094875H NG2094877H NG2094879H NG2094881H NG2094883H NG2094884H NG2094886H NG2094890H NG2094892H NG2094903H NG2094905H NG2094906H NG2094908H NG2094910H NG2094912H NG2094914H NG2094916H NG2094919H NG2094921H NG2094923H NG2094925H NG2094926H NG2094929H NG2094930H NG2094931H NG2094932H NG2094933H NG2094934H NG2094936H NG2094937H NG2094939H NG2094941H NG2094945H NG2094947H NG2094950H NG2094964H NG2094966H NG2094968H NG2094972H NG2094975H NG2095028H NG2095034H NG2095036H NG2095038H NG2095039H NG2095046H NG2095048H NG2095050H NG2095052H NG2095054H NG2095056H NG2095058H NG2095060H NG2095065H NG2095067H NG2095069H NG2095071H NG2095073H NG2095075H NG2095079H NG2095083H NG2095085H NG2095087H NG2095091H NG2095096H NG2095097H NG2095099H NG2095103H NG2095105H NG2095107H NG2095114H NG2095121H NG2095122H NG2095124H NG2095127H NG2095128H NG2095129H NG2095130H NG2095131H NG2095132H NG2095133H NG2095134H NG2095135H NG2095136H NG2095138H NG2095139H NG2095141H NG2095143H NG2095144H NG2095148H
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2020

MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Missing solder battery connection, which could interrupt power of insulin pump.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85711
Lot/product code:
All serial numbers expiration date- 3 years from date of manufacture: NG2095284H, NG2095319H
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 7, 2020

Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85687
Lot/product code:
Atellica Tube Top Sample Cups, 1 mL, SMN 11069061;  Atellica Tube Top Sample Cups, 2 mL, SMN 11069062;  Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 7, 2020

Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85687
Lot/product code:
Atellica Tube Top Sample Cups, 1 mL, SMN 11069061;  Atellica Tube Top Sample Cups, 2 mL, SMN 11069062;  Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2020

The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
86201
Lot/product code:
OEC 9800, OEC 9900 Elite
Recalling firm:
Ge Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2020

Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85689
Lot/product code:
Lots P9J0368Y  P9J0369Y  P9J0517Y  P9K1300Y
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2020

Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85689
Lot/product code:
Lots P9J1171Y  P9K1395Y  P9K1582Y
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2020

Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85689
Lot/product code:
Lots P9J0241Y  P9J0242Y  P9J0243Y  P9K1140Y  P9K1663Y  P9K1141Y
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2020

Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85689
Lot/product code:
Lots P9J1172Y  P9K0452Y  P9K0453Y  P9K0454Y  P9K1596Y  P0B0996Y
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 18, 2020

CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474 2042084-001-053034 2042084-001-215165 2042084-001-079462 2042084-001-047389 2042084-001-112198 2042084-001-041673 2042084-001-227238 2042084-001-071564 2042084-001-503824 2042084-001-119839 2042084-001-569269 2042084-001-041674 2042084-001-047549 2042084-001-514651 2042084-001-163572 2042084-001-583721 2042084-001-427592 2042084-001-527358 2042084-001-583723 2042084-001-317166 2042084-001-583724 2042084-001-583715 2042084-001-583718 2042084-001-055156 2042084-001-583722 2042084-001-041835 2042084-001-074124 2042084-001-583706 2042084-001-583707 2042084-001-519926 2042084-001-583717 2042084-001-583713 2042084-001-207863 2042084-001-460604 2042084-001-079192 2042084-001-197663 2042084-001-045872 2042084-001-053195 2042084-001-092010 2042084-001-560824 2042084-001-052372 2042084-001-071088 2042084-001-046667 2042084-001-213006 2042084-001-086202 2042084-001-301821 2042084-001-045720 2042084-001-060454 2042084-001-418294 2042084-001-088907 2042084-001-065769 2042084-001-589530 2042084-001-623792 2042084-001-187563 2042084-001-320333 2042084-001-357143 2042084-001-148302 To be provided 2042084-001-082825 2042084-001-057016 2042084-001-153601 2042084-001-161552 2042084-001-140229 2042084-001-611704 2042084-001-626688 2042084-001-389208 2042084-001-657836 2042084-001-225214 2042084-001-503162 2042084-001-477881 2042084-001-316025 2042084-001-046826 2042084-001-245255 2042084-001-196543 2042084-001-557725 2042084-001-505890 2042084-001-218596 2042084-001-336980 2042084-001-524525 2042084-001-600032 2042084-001-529732 2042084-001-195742 2042084-001-195782 2042084-001-573889 2042084-001-573890 2042084-001-573886 2042084-001-573887 2042084-001-195822 2042084-001-195862 2042084-001-048420 2042084-001-065538 2042084-001-055814 2042084-001-341260 2042084-001-149220 2042084-001-079193 2042084-001-229282 2042084-001-629486 2042084-001-058695 2042084-001-061170 2042084-001-629548 2042084-001-080803 2042084-001-596662 2042084-001-250146 2042084-001-202515 2042084-001-515709 2042084-001-579491 2042084-001-505608 2042084-001-065010 2042084-001-619171

The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85765
Lot/product code:
All Model Numbers that contain software versions 2.6 or 2.7
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 19, 2020

Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1279-2020
Lot/product code:
Batch #: 170731, Exp 2020.07; 180504; Exp 2021.05
Recalling firm:
Wuhan Bingbing Pharmaceutical Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 19, 2020

LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1278-2020
Lot/product code:
Batch #: 170527, Exp 2020.05
Recalling firm:
Wuhan Bingbing Pharmaceutical Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 19, 2020

Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1280-2020
Lot/product code:
Batch #: 170614, Exp 2020.06.13; 180108, Exp 2021.01.07; 180109, Exp 2021.01.08; 180110, Exp 2021.01.09; 180111, Exp 2021.01.10, 180112, Exp 2021.01.11; 180113, Exp 2021.01.12; 180317, Exp 2021.03.16; 180318, Exp 2021.03.17
Recalling firm:
Wuhan Bingbing Pharmaceutical Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 19, 2020

LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1277-2020
Lot/product code:
Batch #: 1180103, Exp 2021.01.02; 180104, Exp 2021.01.03; 80105, Exp 2021.01.04; 180106, Exp 2021.01.05; 80107, Exp 2021.01.06.
Recalling firm:
Wuhan Bingbing Pharmaceutical Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2020

Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85793
Lot/product code:
Serial Numbers: SY-01-00358350-11 SY-01-00048100 SY-01-01421950-151 SY-01-0080093778 SY-01-00745300 SY-01-0080087818 SY-01-00358350-16 SY-01-00544800 SY-01-01333000-34 SY-01-07012810 SY-01-0080082385 SY-01-0080078513 SY-01-07059500 SY-01-01333000-07 SY-01-01333000-20 SY-01-01333000-34 SY-01-07302600 SY-01-00127000 SY-01-07038976 SY-01-01487000-02 SY-01-00272120 SY-01-00349940 SY-01-00233520 SY-01-0080087409 SY-01-00233710 SY-01-00358350-03 SY-01-00236550 SY-01-0052282 SY-01-00254800-02 SY-01-000254800 SY-01-00269450 SY-01-07039120-01 SY-01-00272350-01 SY-01-00272410 SY-01-00106300 SY-01-00316710 SY-01-00277570-04 SY-01-00322350 SY-01-00322360 SY-01-07055566 SY-01-00493810-327 SY-01-01487000-01 SY-01-07060430-01 SY-01-80096794 SY-01-0079187 SY-01-09003000 SY-01-00465550 SY-01-00493810-112 SY-02-01138010-47 SY-01-00463100 SY-01-00493810-340 SY-01-0080092404 SY-01-00586560 SY-01-00591100 SY-01-00593500-01 SY-01-0080076025 SY-01-01447400-01 SY-01-00493810-155 SY-01-07127057 SY-0180097541 SY-01-00605610 SY-01-00616700-02 SY-01-0080053255 SY-01-0080080176 SY-01-00658580-01 SY-01-00228750-01 SY-01-01687500 SY-01-0080057825 SY-01-00693860 SY-01-0080071248 SY-01-00798760 SY-01-00804700-01 SY-01-0074955 SY-01-0080055290 SY-01-0080074389 SY-01-07160281 SY-01-0077489 SY-01-00873500 SY-01-07163410 SY-0080053050-001 SY-01-00103613 SY-01-00899150 SY-01-00816310 SY-01-0080094741 SY-01-07182322 SY-01-00971200 SY-01-0080092600 SY-01-80097226 SY-01-01034770 SY-01-09625000 SY-01-01072260 SY-01-01446300 SY-01-00769050-01 SY-01-01079071 SY-01-00493810-137 SY-01-00439700-10 SY-02-00858500 SY-01-07274900-01 SY-01-00493810-157 SY-01-01421950-26 SY-01-01134010 SY-01-00082610 SY-01-07242000 SY-01-00493810-300 SY-01-00949090 SY-01-00493810-97 SY-01-0080073752 SY-01-00322221 SY-01-05050280-60 SY-01-08131000 SY-01-01255600-03 SY-01-01272111 SY-01-07264334 SY-01-01401510-02 SY-01-80060398 SY-01-00493810-54 SY-01-01430700 SY-01-01447400 SY-01-01451260 SY-01-01318310 SY-01-00529515 SY-01-01327350 SY-01-01482450 SY-01-01489350 SY-01-01558860 SY-01-01573510 SY-01-00822790 SY-01-0080087769 SY-03-00070210 SY-01-07214790 SY-01-01717500-15 SY-01-00398300-10 SY-01-0080072627 SY-01-0080055858 SY-01-0080055213
Recalling firm:
Fujifilm Medical Systems U.S.A., Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 26, 2020

RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2

It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85796
Lot/product code:
Software versions 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 and 9.2.0.483
Recalling firm:
RAYSEARCH LABORATORIES AB
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 27, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1303-2020
Lot/product code:
All lots remaining within expiry
Recalling firm:
Apotex Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1345-2020
Lot/product code:
AM180641A 6/30/2020 AM180642A 6/30/2020 AM180643A 6/30/2020 AM180644A 6/30/2020 AM180645A 6/30/2020 AM180646A 6/30/2020 AM180647A 6/30/2020 AM180880A 7/31/2020 AM180881A 7/31/2020 AM180882A 7/31/2020 AM180883A 7/31/2020 AM180884A 7/31/2020 AM180885A 7/31/2020 AM180886A 7/31/2020 AM180887A 7/31/2020 AM180888A 7/31/2020 AM180889A 7/31/2020 AM180936A 7/31/2020 AM180937A 7/31/2020 AM180938A 7/31/2020 AM180939A 7/31/2020 AM180940A 7/31/2020 AM180960A 7/31/2020 AM180961A 7/31/2020 AM180962A 7/31/2020 AM180963A 7/31/2020 AM180964A 7/31/2020 AM180965A 7/31/2020 AM180992A 7/31/2020 AM180993A 7/31/2020 AM180994A 8/31/2020 AM180995A 8/31/2020 AM180996A 8/31/2020 AM180997A 8/31/2020 AM181037A 8/31/2020 AM181038A 8/31/2020 AM181039A 8/31/2020 AM181040A 8/31/2020 AM181041A 8/31/2020 AM181079A 8/31/2020 AM181080A 8/31/2020 AM181081A 8/31/2020 AM181082A 8/31/2020 AM181083A 8/31/2020 AM181084A 8/31/2020 AM181085A 8/31/2020 AM181086A 8/31/2020 AM181087A 8/31/2020 AM181088A 8/31/2020 AM181089A 8/31/2020 AM181093A 8/31/2020 AM181094A 8/31/2020 AM181095A 8/31/2020 AM181096A 8/31/2020 AM181097A 8/31/2020 AM181098A 8/31/2020 AM181099A 8/31/2020 AM181100A 8/31/2020 AM181101A 8/31/2020 AM181102A 8/31/2020 AM181116A 8/31/2020 AM181117A 9/30/2020 AM181129A 8/31/2020 AM181130A 8/31/2020 AM181131A 8/31/2020 AM181132A 8/31/2020 AM181133A 9/30/2020 AM181134A 9/30/2020 AM181135A 9/30/2020 AM181136A 9/30/2020 AM181137A 9/30/2020 AM181138A 9/30/2020 AM181183A 9/30/2020 AM181184A 9/30/2020 AM181185A 9/30/2020 AM181186A 9/30/2020 AM181187A 9/30/2020 AM181188A 9/30/2020 AM181189A 9/30/2020 AM181190A 9/30/2020 AM181235A 9/30/2020 AM181236A 9/30/2020 AM181237A 9/30/2020 AM181238A 9/30/2020 AM181239A 9/30/2020 AM181240A 9/30/2020 AM181242A 9/30/2020 AM181243A 9/30/2020 AM181314A 10/31/2020 AM181315A 11/30/2020 AM190121B 12/31/2020 AM190122B 12/31/2020 AM190713AA 6/30/2021 AM191248A 10/31/2021 AM191249A 10/31/2021 AM200192 1/31/2022 AM200322A 2/28/2022
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1343-2020
Lot/product code:
HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021; HB00419A 2/28/2021 HB00519A 2/28/2021 HB00619A 2/28/2021 HB00719A 2/28/2021 HB00819A 2/28/2021 HB00919A 2/28/2021 HB01019A 2/28/2021 HB05119A 2/28/2021 HB05219A 2/28/2021 HB05319A 2/28/2021 HB05419A 2/28/2021 HB05519A 2/28/2021 HB09519A 2/28/2021 HB09619A 2/28/2021 HB09719A 2/28/2021 HB09819A 2/28/2021 HB09919A 2/28/2021; HC08219A 3/31/2021 HC08319A 3/31/2021 HC08419A 3/31/2021 HC08519A 3/31/2021 HC09019A 3/31/2021 HC09119A 3/31/2021 HC09219A 3/31/2021 HC09319A 3/31/2021 HC09419A 3/31/2021; HD03419B 4/30/2021 HD03519B 4/30/2021 HD03619B 4/30/2021 HD03719B 4/30/2021 HD03819B 4/30/2021 HD03919B 4/30/2021 HD04019B 4/30/2021 HD04119B 4/30/2021 HD04219A 4/30/2021 HD05819A 4/30/2021 HD05919A 4/30/2021 HD06019A 4/30/2021 HD06119A 4/30/2021 HD06219A 4/30/2021 HD06319A 4/30/2021 HD06419A 4/30/2021 HD09019A 4/30/2021 HD09119A 4/30/2021 HD09219A 4/30/2021 HE01219B 4/30/2021 HE01319B 4/30/2021 HE01419B 4/30/2021 HE01519B 4/30/2021; HE01619A 5/31/2021 HE01719A 5/31/2021 HE01819A 5/31/2021 HE04419A 5/31/2021 HE04519A 5/31/2021 HE04619A 5/31/2021 HE04719A 5/31/2021 HE04819A 5/31/2021 HE04919A 5/31/2021 HE05019A 5/31/2021 HE05119A 5/31/2021 HE05219A 5/31/2021 HE05319A 5/31/2021 HE07219A 5/31/2021 HE07319A 5/31/2021 HE07419A 5/31/2021 HE07519A 5/31/2021 HE07619A 5/31/2021 HF02219A 5/31/2021 HF02319A 5/31/2021; HF02419A 6/30/2021 HF02519A 6/30/2021 HF02619A 6/30/2021 HF02719A 6/30/2021 HF02819A 6/30/2021 HF02919A 6/30/2021 HF03019A 6/30/2021 HF03119A 6/30/2021 HF03219A 6/30/2021 HF03319A 6/30/2021 HF05419A 6/30/2021; HF03918A 6/30/2020 HF04018A 6/30/2020 HF04118A 6/30/2020 HF04218A 6/30/2020 HF04318A 6/30/2020 HF04418A 6/30/2020 HF06518A 6/30/2020 HF06818B 6/30/2020 HF06918B 6/30/2020 HF07018B 6/30/2020 HF07118B 6/30/2020 HF07218A 6/30/2020 HF07318A 6/30/2020 HF07418A 6/30/2020 HF08318A 6/30/2020 HF08418A 6/30/2020 HF08518A 6/30/2020; HF11219A 6/30/2021 HF11319A 6/30/2021 HF11419A 6/30/2021 HF11519A 6/30/2021 HF11619A 6/30/2021 HF11719A 6/30/2021 HF11819A 6/30/2021 HF11919A 6/30/2021 HF12019A 6/30/2021 HG00719A 6/30/2021 HG00819A 6/30/2021 HG00919A 6/30/2021 HG01019A 6/30/2021 HG01119A 6/30/2021 HG01219A 6/30/2021 HG01319A 6/30/2021 HG01419A 6/30/2021; HG01519A 7/31/2021 HG01619A 7/31/2021 HG02919A 7/31/2021 HG03019A 7/31/2021 HG03119A 7/31/2021 HG03219A 7/31/2021 HG03319A 7/31/2021 HG03419A 7/31/2021 HG03519A 7/31/2021 HG03619A 7/31/2021 HG03719A 7/31/2021 HG03819A 7/31/2021; HH08218A 8/31/2020 HH08318A 8/31/2020 HH08418A 8/31/2020 HH08518A 8/31/2020 HH08618A 8/31/2020 HH08718A 8/31/2020 HH08818A 8/31/2020 HH08918A 8/31/2020 HH09018A 8/31/2020 HH09118A 8/31/2020 HH09218A 8/31/2020 HH09318A 8/31/2020 HH09418A 8/31/2020 HH09518A 8/31/2020 HH09618A 8/31/2020 HH11218A 8/31/2020 HH11318A 8/31/2020 HH11418A 8/31/2020 HH11518A 8/31/2020; HH11618A 9/30/2020 HH11718A 9/30/2020 HJ04818A 9/30/2020 HJ04918A 9/30/2020 HJ08518A 9/30/2020; HJ08618A 10/31/2020 HJ08718A 10/31/2020 HJ08818A 10/31/2020 HJ08918A 10/31/2020 HJ09018A 10/31/2020 HJ09118A 10/31/2020 HK03718A 10/31/2020 HK03818A 10/31/2020 HK03918A 10/31/2020 HK04018A 10/31/2020 HK04118A 10/31/2020 HK04218A 10/31/2020 HK04318A 10/31/2020 HK04418A 10/31/2020 HK04518A 10/31/2020 HK04618A 10/31/2020 HK09318A 10/31/2020 HK09418A 10/31/2020 HK09518A 10/31/2020 HK09618A 10/31/2020 HK09718A 10/31/2020; HM00218A 12/31/2020 HM00318A 12/31/2020 HM00418A 12/31/2020 HM00518A 12/31/2020 HM00618B 12/31/2020 HM00718B 12/31/2020 HM00818B 12/31/2020 HM00918B 12/31/2020 HM01018B 12/31/2020; HM02918A 1/31/2021 HM03018A 1/31/2021 HM03218A 1/31/2021 HM03318A 1/31/2021 HM03418A 1/31/2021 HM03518A 1/31/2021 HM03618A 1/31/2021 HM03718A 1/31/2021 HM03818A 1/31/2021
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1344-2020
Lot/product code:
AM190123A 1/31/2021 AM190193A 1/31/2021 AM190194A 1/31/2021 AM190195A 1/31/2021 AM190196A 1/31/2021 AM190197A 1/31/2021 AM190198A 1/31/2021 AM190199A 1/31/2021 AM190200A 2/28/2021 AM190201A 2/28/2021 AM190202A 2/28/2021 AM190269A 2/28/2021 AM190270A 2/28/2021 AM190271A 2/28/2021 AM190272A 2/28/2021 AM190289A 2/28/2021 AM190290A 2/28/2021 AM190291A 2/28/2021 AM190292A 2/28/2021 AM190293A 2/28/2021 AM190294A 2/28/2021 AM190549A 4/30/2021 AM190550A 4/30/2021 AM190551A 4/30/2021 AM190552A 4/30/2021 AM190553A 4/30/2021 AM190554A 4/30/2021 AM190555A 5/31/2021 AM190556A 5/31/2021 AM190586A 5/31/2021 AM190587A 5/31/2021 AM190588A 5/31/2021 AM190589A 5/31/2021 AM190590A 5/31/2021 AM190605A 5/31/2021 AM190673A 6/30/2021 AM190707A 6/30/2021 AM190708A 6/30/2021 AM190709A 6/30/2021 AM190710A 6/30/2021 AM190714C 6/30/2021 AM190751C 6/30/2021 AM190752C 6/30/2021 AM190753A 8/31/2021 AM190754A 8/31/2021 AM190755A 8/31/2021 AM190756A 8/31/2021 AM190757A 8/31/2021 AM190929A 8/31/2021 AM190930A 8/31/2021 AM190931A 8/31/2021 AM190932A 8/31/2021 AM190933A 8/31/2021 AM190995A 8/31/2021 AM191000A 8/31/2021 AM191001A 8/31/2021 AM191002A 8/31/2021 AM191003A 8/31/2021 AM191034A 9/30/2021 AM191035A 9/30/2021 AM191036A 9/30/2021 AM191037A 9/30/2021 AM191038A 9/30/2021 AM191039A 9/30/2021 AM191086A 9/30/2021
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)