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Recalls affecting Hawaii

Data last updated: September 8, 2026 at 1:13 PM UTC

16,268 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 Men — dietary 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/virusAnnounced September 4, 2026

Foods Alive — Moringa 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. Braun — 0.9% 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/virusAnnounced September 3, 2026

Great Value — Organic 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

Lipofit — Lipofit 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

Kofinas — Garlic 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)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey 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/virusAnnounced August 29, 2026

Everything Sprouts — Robust 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/virusAnnounced August 29, 2026

Martina — Mangoes

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)
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UnclassifiedRisk not yet known
Medical deviceRecalled October 3, 2018

Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)

Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
81246
Lot/product code:
Serial Numbers NG1330099H NG1330154H NG1329859H NG1330107H NG1330110H NG1330113H NG1330122H NG1330133H NG1330136H NG1330140H NG1330142H NG1330143H NG1330145H NG1330160H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1330145H NG1330160H NG1330160H NG1330145H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1399727H NG1399183H NG1399310H NG1400412H NG1399761H NG1399740H NG1399750H NG1400409H NG1400138H NG1400067H NG1400445H NG1400080H NG1400332H NG1400078H NG1400458H NG1400416H NG1400350H NG1400420H NG1400003H NG1399926H NG1400448H NG1400674H NG1400159H NG1399266H NG1400140H NG1400562H NG1400509H NG1400346H NG1399206H NG1400293H NG1400164H NG1399776H NG1399708H NG1399738H NG1400077H NG1399562H NG1399623H NG1399101H NG1399268H NG1398858H NG1399624H NG1399345H NG1399574H NG1399614H NG1398932H NG1398948H NG1399462H NG1399530H NG1399210H NG1399441H NG1399997H NG1400051H NG1400054H NG1400106H NG1400292H NG1399923H NG1400072H NG1399663H NG1399669H NG1400151H NG1400353H NG1400410H NG1400434H NG1399757H NG1399680H NG1399890H NG1399622H NG1399674H NG1399613H NG1399892H NG1399015H NG1399389H NG1399467H NG1398249H NG1398312H NG1399185H NG1398301H NG1399497H NG1398015H NG1398434H NG1398130H NG1398062H NG1398063H NG1399103H NG1399175H NG1399107H NG1399352H NG1399527H NG1399176H NG1399443H NG1399472H NG1399202H NG1399057H NG1399182H NG1399271H NG1398692H NG1398937H NG1398670H NG1398550H NG1398795H NG1398647H NG1398751H NG1398667H NG1398555H NG1398646H NG1400170H NG1400154H NG1400282H NG1400160H NG1400148H NG1400438H NG1400482H NG1399894H NG1400512H NG1400481H NG1398852H NG1400471H NG1400513H NG1400569H NG1400206H NG1400477H NG1400575H NG1400068H NG1400572H NG1400480H NG1400344H NG1400473H NG1400453H NG1397889H NG1397914H NG1398297H NG1397901H NG1399354H NG1399284H NG1399633H NG1399445H NG1399495H NG1399413H NG1399636H NG1399054H NG1399020H NG1399195H NG1399196H NG1398467H NG1394992H NG1399334H NG1398931H NG1399079H NG1399213H NG1398385H NG1399180H NG1398839H NG1399058H NG1398919H NG1399113H NG1399435H NG1399494H NG1399384H NG1398800H NG1398455H NG1398444H NG1398470H NG1398435H NG1398304H NG1398443H NG1399407H NG1398293H NG1399567H NG1398918H NG1399019H NG1399375H NG1399312H NG1399320H NG1398032H NG1399379H NG1399318H NG1398940H NG1399083H NG1399177H NG1399313H NG1399012H NG1399204H NG1399105H NG1398084H NG1398289H NG1399404H NG1398910H NG1398451H NG1399246H NG1399188H NG1398728H NG1398237H NG1399056H NG1398832H NG1399021H NG1399569H NG1398439H NG1398502H NG1399263H NG1398475H NG1399564H NG1399016H NG1399416H NG1399095H NG1398936H NG1399339H NG1398305H NG1398433H NG1399186H NG1399256H NG1398650H NG1398663H NG1399707H NG1399615H NG1398464H NG1399244H NG1399218H NG1399080H NG1399013H NG1398553H NG1398569H NG1398563H NG1399084H NG1399474H NG1398941H NG1398909H NG1399250H NG1399051H NG1398915H NG1398837H NG1398817H NG1398857H NG1399565H NG1399248H NG1398928H NG1399323H NG1399216H NG1399259H NG1399634H NG1398916H NG1398924H NG1399629H NG1399748H NG1398828H NG1399491H NG1399448H NG1399492H NG1398759H NG1399452H NG1399252H NG1399401H NG1399575H NG1399187H NG1398694H NG1398677H NG1398544H NG1399332H NG1398673H NG1399091H NG1399576H NG1398792H NG1399418H NG1399017H NG1399100H NG1399493H NG1399289H NG1398438H NG1398763H NG1399050H NG1399208H NG1398860H NG1399225H NG1398652H NG1398686H NG1398691H NG1398651H NG1398695H NG1398566H NG1398515H NG1399692H NG1404598H NG1404947H NG1404897H NG1404932H NG1405462H NG1405014H NG1405246H NG1405244H NG1405377H NG1404732H NG1400167H NG1399671H NG1399925H NG1399916H NG1399991H NG1400050H NG1399928H NG1400411H NG1400045H NG1400172H NG1400446H NG1400162H NG1399743H NG1400284H NG1400046H NG1400042H NG1400436H NG1400005H NG1400287H NG1400424H NG1399993H NG1400312H NG1399184H NG1399709H NG1399573H NG1399885H NG1399566H NG1399934H NG1399999H NG1405228H NG1404682H NG1405263H NG1405242H NG1404756H NG1404895H NG1404726H NG1404617H NG1404728H NG1405042H NG1404520H NG1404892H NG1404625H NG1404938H NG1405510H NG1404785H NG1404944H NG1405291H NG1404940H NG1405223H NG1405190H NG1405248H NG1405285H NG1405229H NG1404840H NG1404879H NG1405261H NG1404655H NG1405376H NG1405237H NG1405293H NG1404965H NG1405450H NG1404687H NG1404953H NG1404823H NG1405232H NG1405257H NG1404731H NG1404700H NG1399719H NG1400070H NG1399882H NG1399617H NG1399621H NG1399714H NG1399777H NG1398793H NG1399759H NG1398649H NG1398917H NG1398853H NG1399090H NG1398834H NG1401004H NG1400737H NG1401014H NG1401012H NG1401016H NG1400701H NG1394712H NG1343244H NG1398802H NG1394999H NG1343246H NG1343253H NG1394985H NG1343249H NG1394967H NG1400682H NG1405554H NG1405378H NG1398812H NG1398738H NG1399053H NG1400734H NG1395001H NG1394982H NG1394997H NG1400546H NG1399342H NG1400063H NG1400044H NG1399896H NG1399905H NG1399198H NG1399178H NG1399659H NG1399898H NG1398863H NG1400064H NG1399772H NG1400069H NG1399316H NG1399631H NG1399918H NG… (truncated, 1638277 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled October 4, 2018

Callie's Charleston Biscuits COUTRY HAM BISCUITS; 18 NET WT. 18 OZ (510 g) Callie's Charleston Biscuits; 1895 Avenue F, Charleston, SC 18405 843 577.1198; CALLIESBISCUITS.COM

The firm was notified by one of their vendors that the ham used in their product may be contaminated with Listeria monocytogenes

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVOHOKORPARISCSDTNTXUTVAVTWAWIWVWY
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
F-0067-2019
Lot/product code:
050417, 052417, 053017, 071017, 072417, 080117, 081417, 082217, 091417, 092717, 101017, 101117, 102417, 110617, 110817, 111417, 112017, 113017, 120817, 121117, 121417, 121817, 122217, 070219, 071519, 081319, 082619, 090819, 091519, 092619, 092719, 101019, 101619, 102319, 110119, 111119, 111419, 112919, 121319, 122119, 010920, 013020, 020620 & 031920.
Recalling firm:
Callie's Charleston Biscuits
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled October 4, 2018

Callie's Charleston Biscuits COCKTAIL HAM BISCUITS; 24 NET WT. 35 OZ (980 g) Callie's Charleston Biscuits; 1895 Avenue F, Charleston, SC 18405 843 577.1198; CALLIESBISCUITS.COM

The firm was notified by one of their vendors that the ham used in their product may be contaminated with Listeria monocytogenes

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVOHOKORPARISCSDTNTXUTVAVTWAWIWVWY
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
F-0066-2019
Lot/product code:
050417, 060617, 060717, 080117, 091917, 092717, 110617, 120417, 121617, 070619, 080819, 101019, 102319, 110119, 111419, 122119 & 010920.
Recalling firm:
Callie's Charleston Biscuits
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 10, 2018

IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet.

ALL 50 STATES
▸Full report

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

Recall #:
81531
Lot/product code:
All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)
Recalling firm:
Philips Electronics North America Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 16, 2018

Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box

Potential that gauze pads may not be fully sterilized

ALL 50 STATES
▸Full report

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

Recall #:
81555
Lot/product code:
ASO Item No. 780655, Batch/Lot # 2384-20180524
Recalling firm:
ASO, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 17, 2018

Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.

There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen.

ALL 50 STATES
▸Full report

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

Recall #:
81169
Lot/product code:
All lot numbers manufactured from October 30, 2006 to August 15, 2018, with affected Product and Lot Numbers distributed worldwide - Product Number (Lot Numbers):  825200641 (1271924, 1074548, 1186516, 1364805, 1262505, 1269165, 1313148, 1296901, 1330427, 1382941, 1321674, 1339578, 1265501, 1344236,  1261415, 1372437, 1353961, M054680, M118520, 1003492, 1058979, 1287750);   825200842 (1189516, 1074551, 1319855, 1298913, 1057370, M054700, M118540);   825201041 (1269824, 1277860, 1186520, 1195261, 1230705, 1340401, 1253661, 1263078, 1288520, 1186520 , 1227431, 1368550, 1376018, 1382289, 1316167, 1104163, 1074553, 1307329, 1296285, 1332473, 1319856, 1053400, 1337541, M054720, M118550);   825201241 (1185831, 1372500, 1364881, 1238365, 1273017, 1302457, 1298771, 1186521, 1269168, 1183846, 1323532, 1074555, 1316169, 1344797,  1333774, 1057371, 1361470, 1265502, 1289744, M054730, M118560);   825201441 (1185832, 1189518, 1339287, 1274102, 1281289, 1320136, 1314041, 1360269, 1328548, 1003493, 1074556, M054740, M112910);   825210830 (1264551, 1313443, 1338468, 1212278, 1262656, 1271357, 1320727);   825211030 (1271954, 1293167, 1287813, 1313444, 1265025, 1320728, 1212279, 1342362);   825211230 (1240940, 1253421, 1245260);   825211430 (1253422, 1240941);   825200841 (1274105, 1185829, 1281667, 1257138, 1368638, 1306948, 1265989, 1296284, 1298436, 1189515, 1269820, 1319630, 1376097, 1362251, 1323968, 1107980, 1333771, 1261416, 1378166, 1053398, 1338467, 1288856, 1074550, M054690, M118530, 1241165, 1243611, 1248730, 1253658, 1262506);   Affected Part and Lot numbers distributed Nationwide - Part Number (Lot Numbers):  82520.0641 (1058979, 1074548, 1339578, 1003492, 1313148, M054680, 1186516, 1271924, 1262505, 1269165, 1296901, 1364805, 1330427, 1344236,  M118520, 1287750, 1353961, 1382941);   82520.0841 (1074550, 1333771, 1323968, M054690, 1281667, 1274105, 1241165, 1053398, 1269820, 1243611, 1248730, 1262506, 1288856, 1298436, M118530, 1362251, 1185829, 1198515, 1338467, 1378166, 1253658, 1296284);   82520.0842 (M118540, M054700, 1189516, 1319855);   82520.1041 (1074553, 1319856, 1316167, 1277860, M054720, 1053400, 1269824, 1230705, 1253661, 1263078, 1376018, 1288520, 1332473, M118550, 1337541, 1186520, 1195261, 1382289);   82520.1241 (1074555, 1333774, 1302457, 1057371, M054730, 1269168, M118560, 1238365, 1186521, 1289744, 1372500, 1298771, 1344797, 1361470, 1265502, 1185831);   82520.1441 (1074556, 1320136, 1003493, 1314041, 1281289, M054740,  M112910, 1189518, 1360269, 1274102, 1339287, 1328548);   825210830 (1271357, 1313443, 1212278, 1262656, 1320727, 1264551, 1338468);   825211030 (1320728, 1313444, 1212279, 1265025, 1342362, 1293167, 1287813);   825211230 (1245260, 1253421, 1240940);   825211430 (1240941, 1253422)
Recalling firm:
Richard Wolf GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2018

VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.

The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.

ALL 50 STATES
▸Full report

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

Recall #:
81682
Lot/product code:
All expired, in-date, and future lots released.
Recalling firm:
ORTHO-CLINICAL DIAGNOSTICS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2018

VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.

ALL 50 STATES
▸Full report

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

Recall #:
81682
Lot/product code:
All expired, in-date, and future lots released.
Recalling firm:
ORTHO-CLINICAL DIAGNOSTICS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 1, 2018

VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Test results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection. The VITROS HBeAg test should not be used to test cord blood samples. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.

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▸Full report

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

Recall #:
81682
Lot/product code:
All expired, in-date, and future lots released.
Recalling firm:
ORTHO-CLINICAL DIAGNOSTICS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2018

GEM Coupler Forceps, GEM4183C, packaged individually.

Potential presence of rust on Coupler Forceps (GEM4183C).

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▸Full report

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

Recall #:
81581
Lot/product code:
Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 13, 2018

EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.

There is a potential the joint in the suspension of the device is insufficiently assembled.

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

Recall #:
82476
Lot/product code:
Serial numbers 100000000065406 to 100000000106685.
Recalling firm:
Stryker Communications
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 15, 2018

Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

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▸Full report

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

Recall #:
81595
Lot/product code:
GTIN Number - 10884521706590 Lot Numbers-  S7HG001PX S7HG004KX S7HG010KX S7HG011KX S7HG012KX S7HG030LX S7HG031LX S7HG035LX S7HG039LX S7HG042LX S7HG043X S7JG006X S7JG010X S7JG013X S7JG014X S7KG008LX S7KG009LX S7KG010LX S7KG041X S7KG043X S7LG003X S7LG004X S7MG003X S7MG004LX S7MG017PX S7MG029X S8BG001X S8BG002X S8BG006X S8CG001X S8CG008LX S8CG009X S8CG018X S8CG023X S8DG019LX S8DG020LX S8DG021LX S8DG022LX S8DG023X S8DG025X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 15, 2018

Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

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▸Full report

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

Recall #:
81595
Lot/product code:
GTIN Number - 10884521706606 Lot Numbers-  S7HG007KX S7HG008KX S7HG009KX S7HG032LX S7HG033LX S7HG034LX S7JG008LX S7JG009X S7JG012X S7KG012LX S7KG038QX S7LG009X S7MG010LX S7MG019X S8BG004X S8BG005X S8CG002X S8DG001X S8DG026X S8EG004X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 15, 2018

Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

ALL 50 STATES
▸Full report

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

Recall #:
81595
Lot/product code:
GTIN Number - 10884521706583 Lot Numbers-  S7HG002X S7HG003X S7HG005KX S7HG006KX S7HG022LX S7HG023LX S7HG024LX S7HG025LX S7HG029LX S7HG040X S7HG041X S7HG045X S7HG049X S7JG007X S7JG011X S7JG033LX S7JG034X S7JG035X S7JG041LX S7JG042LX S7JG043LX S7JG044LX S7JG045LX S7JG046LX S7JG047LX S7KG023LX S7KG029X S7KG033X S7KG039X S7KG040X S7KG042X S7LG001X S7LG002X S7LG006X S7LG011X S7LG012X S7MG008LX S7MG009LX S7MG011X S7MG012X S7MG014X S7MG018X S7MG020X S7MG021X S7MG022PX S7MG023PX S7MG024X S7MG025X S7MG026X S8AG001X S8AG002X S8AG011X S8AG013X S8CG004X S8CG010X S8CG017X S8CG019PX S8CG022PX S8CG025X S8DG014LX S8DG015LX S8DG016LX S8DG017LX S8DG018LX S8DG024X S8DG027X S8EG005X S8EG009X S8EG010X S8EG011X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 16, 2018

The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210.

Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNYOHOKORPARISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
82566
Lot/product code:
Serial Numbers Less Than 100000
Recalling firm:
LivaNova USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 16, 2018

VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENJNMNVNYOHOKORPASCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
84170
Lot/product code:
Serial Number / UDI# GWQ57F2 01054250257504811118060521GWQ57F29910-0011-0500 72S77F2 0105425025750481111806052172S77F29910-0011-0500 1ZFTKJ2 010542502575048111180604211ZFTKJ29910-0011-0500 BRQ57F2 01054250257504811118053121BRQ57F29910-0011-0500 9CP57F2 010542502575048111180529219CP57F29910-0011-0500 HCR77F2 01054250257504811118050421HCR77F29910-0011-0500 H5P57F2 01054250257504811118050321H5P57F29910-0011-0500 19S77F2 0105425025750481111804172119S77F29910-0011-0500 3YFTKJ2 010542502575048111180405213YFTKJ29910-0011-0500 68Q57F2 0105425025750481111803302168Q57F29910-0011-0500 H4S77F2 01054250257504811118031521H4S77F29910-0011-0500 C7KRPJ2 01054250257504811118031521C7KRPJ29910-0011-0500 8WQ77F2 010542502575048111180315218WQ77F29910-0011-0500 1VQ77F2 010542502575048111180315211VQ77F29910-0011-0500 1LJRPJ2 010542502575048111180315211LJRPJ29910-0011-0500 JFJRPJ2 01054250257504811118031421JFJRPJ29910-0011-0500 HVP57F2 01054250257504811118031421HVP57F29910-0011-0500 CBJRPJ2 01054250257504811118031421CBJRPJ29910-0011-0500 9HJRPJ2 010542502575048111180314219HJRPJ29910-0011-0500 1LQ57F2 010542502575048111180313211LQ57F29910-0011-0500 B6S77F2 01054250257504811118030921B6S77F29910-0011-0500 5NT77F2 010542502575048111180309215NT77F29910-0011-0500 75P57F2 0105425025750481111803052175P57F29910-0011-0500 32S77F2 0105425025750481111803052132S77F29910-0011-0500 6P7G1F2 010542502575048111180302216P7G1F29910-0011-0500 1J0C7F2 010542502575048111180228211J0C7F29910-0011-0500 J4R57F2 01054250257504811118022721J4R57F29910-0011-0500 61R77F2 0105425025750481111802272161R77F29910-0011-0500 1C0C7F2 010542502575048111180227211C0C7F29910-0011-0500 1LYB7F2 010542502575048111180226211LYB7F29910-0011-0500 DPS77F2 01054250257504811118021521dps77f29910-0011-0500 9LQ57F2 010542502575048111180215219lq57f29910-0011-0500 HDR77F2 01054250257504811118021421HDR77F29910-0011-0500 B5S77F2 01054250257504811118021421B5S77F29910-0011-0500 HCJRPJ2 01054250257504811118020721HCJRPJ29910-0011-0500 CCT77F2 01054250257504811118020721CCT77F29910-0011-0500 6BR77F2 010542502575048111180207216BR77F29910-0011-0500 4GR77F2 010542502575048111180207214GR77F29910-0011-0500 HDQ57F2 01054250257504811118020621HDQ57F29910-0011-0500 HBKRPJ2 01054250257504811118020621HBKRPJ29910-0011-0500 D9T77F2 01054250257504811118020621D9T77F29910-0011-0500 56JRPJ2 0105425025750481111802062156JRPJ29910-0011-0500 4CR77F2 010542502575048111180206214CR77F29910-0011-0500 2FT77F2 010542502575048111180206212FT77F29910-0011-0500 HWJRPJ2 01054250257504811118020521HWJRPJ29910-0011-0500 9LJRPJ2 010542502575048111180205219LJRPJ29910-0011-0500 F9T0QJ2 01054250257504811118020221F9T0QJ29910-0011-0500 BSZ1QJ2 01054250257504811118020221BSZ1QJ29910-0011-0500 JCJRPJ2 01054250257504811118020121JCJRPJ29910-0011-0500 BXJRPJ2 01054250257504811118020121BXJRPJ29910-0011-0500 B2Q57F2 01054250257504811118020121B2Q57F29910-0011-0500 9BKRPJ2 010542502575048111180201219BKRPJ29910-0011-0500 7GT77F2 010542502575048111180201217GT77F29910-0011-0500 8JJRPJ2 010542502575048111180131218JJRPJ29910-0011-0500 3QJRPJ2 010542502575048111180131213QJRPJ29910-0011-0500 FNT7QJ2 01054250257504811118011821FNT7QJ29910-0011-0500 CNT7QJ2 01054250257504811118011821CNT7QJ29910-0011-0500 77KRPJ2 0105425025750481111801182177KRPJ29910-0011-0500 1VZ1QJ2 010542502575048111180118211VZ1QJ29910-0011-0500 1QJRPJ2 010542502575048111180118211QJRPJ29910-0011-0500 19T0QJ2 0105425025750481111801182119T0QJ29910-0011-0500 5CD820D5WV 010542502575042911180920215CD820D5WV9910-0011-8701 5CD8212Q6W 010542502575042911180919215CD8212Q6W9910-0011-8701 5CD8212Q6M 010542502575042911180919215CD8212Q6M9910-0011-8701 5CD8212Q57 010542502575042911180919215CD8212Q579910-0011-8701 5CD8212Q55 010542502575042911180919215CD8212Q559910-0011-8701 5CD8212Q51 010542502575042911180919215CD8212Q519910-0011-8701 5CD8212Q44 010542502575042911180919215CD8212Q449910-0011-8701 5CD8212Q1R 010542502575042911180919215CD8212Q1R9910-0011-8701 5CD820D60D 010542502575042911180919215CD820D60D9910-0011-8701 5CD820D5Z6 010542502575042911180919215CD820D5Z69910-0011-8701 5CD820D5WK 010542502575042911180919215CD820D5WK9910-0011-8701 5CD820D5VG 010542502575042911180919215CD820D5VG9910-0011-8701 5CD820D5TP 010542502575042911180919215CD820D5TP9910-0011-8701 5CD820D5TB 010542502575042911180919215CD820D5TB9910-0011-8701 5CD820D5T7 010542502575042911180919215CD820D5T79910-0011-8701 5CD820D5SN 010542502575042911180919215CD820D5SN9910-0011-8701 5CD820D5RT 010542502575042911180919215CD820D5RT9910-0011-8701 5CD820D5R6 010542502575042911180919215CD820D5R69910-0011-8701 5CD8212Q9X 010542502575042911180918215CD8212Q9X9910-0011-8701 5CD8212Q9W 010542502575042911180918215CD8212Q9W9910-0011-8701 5CD8212Q94 010542502575042911180918215CD8212Q949910-0011-8701 5CD8212Q8R 010542502575042911180918215CD8212Q8R9910-0011-8701 5CD8212Q60 010542502575042911180918215CD8212Q609910-0011-8701 5CD8212Q3Y 010542502575042911180918215CD8212Q3Y9910-0011-8701 5CD8212Q3F 010542502575042911180918215CD8212Q3F9910-0011-8701 5CD8212Q33 01… (truncated, 39385 characters total — see the official FDA record for the full value)
Recalling firm:
LivaNova USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2018

Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist

Potentially lead to anchor breakage during insertion,

ALL 50 STATES
▸Full report

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

Recall #:
81819
Lot/product code:
Lots #: 10175216, 1075219, 10199557, and 10199558
Recalling firm:
Arthrex, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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-0312-2019
Lot/product code:
Lot # 3079500, exp. date 1/2020
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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-0318-2019
Lot/product code:
Lot # 3061986, exp. date 11/2018 Lot # 3079709, exp. date 1/2020 Lot # 3077618, exp. date 11/2019 Lot # 3079708, exp. date 1/2020
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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-0316-2019
Lot/product code:
Lot # 3081499, exp. date 3/2020 Lot # 3080009, exp. date 2/2020 Lot # 3080010, exp. date 2/2020 Lot # 3079205, exp. date 1/2020
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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-0313-2019
Lot/product code:
Lot # 3063782, exp. date 1/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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-0315-2019
Lot/product code:
Lot # 3061169, exp. date 11/2018
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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-0317-2019
Lot/product code:
Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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-0311-2019
Lot/product code:
Lot # 3066051, exp. date 3/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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-0314-2019
Lot/product code:
Lot # 3071352, exp. date 7/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)