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Recalls affecting North Dakota

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

16,332 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)
NewestOldest
High riskLow riskAll
Wording
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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-0614-2020
Lot/product code:
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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-0615-2020
Lot/product code:
HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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-0616-2020
Lot/product code:
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60

CGMP Deviations: Presence of NDMA impurity detected in 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-0639-2020
Lot/product code:
7701164A 7701471A 7701670B 7701827A 7702242A 7702705A 7702947A 7703408A 7704494A 7704495A 19190289 19190342 19190372 7702737A
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01

CGMP Deviations: Presence of NDMA impurity detected in 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-0640-2020
Lot/product code:
7701033A 7701826A 7702344A 7702345A 7702489A 7702706A 7702707A 7702708A 7702858A 7702859A 7702860A 7702928A 7702929A 7703196A 7703634A 7704492A 7704493A 7705159A 19190289 19190342 19190372
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30

CGMP Deviations: Presence of NDMA impurity detected in 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-0641-2020
Lot/product code:
7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01

CGMP Deviations: Presence of NDMA impurity detected in 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-0642-2020
Lot/product code:
7701030A 7701031A 7701062A 7701063A 7701110A 7701111A 7701112A 7701185A 7701186A 7701187A 7701188A 7701189A 7701269A 7701270A 7701278A 7701279A 7701386A 7701400A 7701401A 7701406A 7701421A 7701434A 7701435A 7701436A 7701452A 7701453A 7701521A 7701522B 7701553A 7701554A 7701555A 7701556A 7701582A 7701817A 7701828A 7701829A 7702001A 7702002A 7702003A 7702012A 7702026A 7702027A 7702064A 7702140A 7702253A 7702254A 7702285A 7702286A 7702287A 7702288A 7702294A 7702413A 7702462A 7702491A 7702492A 7702504A 7702505A 7702515A 7702698A 7702699A 7702700A 7702714A 7702719A 7702720A 7702747A 7702748A 7702749A 7702750A 7702751A 7702872A 7702873A 7702874A 7702917A 7702918A 7702919A 7702921A 7702922A 7702923A 7702945A 7703205A 7703410A 7703411A 7703412A 7703413A 7703414A 7703415A 7703451A 7703452A 7703453A 7703578A 7703579A 7703580A 7703581A 7703591A 7703592A 7703593A 7704372A 7704373A 7704374A 7704426A 7704427A 7704432A 7704463A 7704464A 7704465A 7704466A 7704508A 7704509A 7704510A 7704511A 7704512A 7704513A 7704563A 7704564A 7704746A 7704747A 7704748A 7704813A 7704841A 7704989A 7704990A 7705106A 7705320A 7705321A 7705322A 7705323A 7705324A 7705325A 7705326A 7705694A 7705703A 7705704A 7705702A 19190456 19190472 19190490 7701809A 7704862A 7704863A 7704864A 7704865A 7704866A 7704933A 7704934A
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05

CGMP Deviations: Presence of NDMA impurity detected in 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-0644-2020
Lot/product code:
7701034A 7701057A 7701058A 7701059A 7701060A 7701061A 7701071A 7701072A 7701073A 7701074A 7701105A 7701106A 7701107A 7701108A 7701109A 7701113A 7701114A 7701115A 7701116A 7701121A 7701122A 7701123A 7701124A 7701125A 7701126A 7701151A 7701152A 7701165A 7701154A 7701155A 7701163A 7701176A 7701190A 7701221A 7701222A 7701223A 7701224A 7701225A 7701235A 7701253A 7701254A 7701255A 7701256A 7701257A 7701258A 7701259A 7701266A 7701267A 7701268A 7701273A 7701275A 7701276A 7701277A 7701294A 7701295A 7701296A 7701297A 7701300A 7701301A 7701302A 7701303A 7701304A 7701306A 7701307A 7701308A 7701309A 7701310A 7701311A 7701312A 7701313A 7701314A 7701315A 7701316A 7701328A 7701329A 7701330A 7701331A 7701332A 7701333A 7701344A 7701153A 7701175A 7701234A 7701274A 7701305A 7701345A 7701352A 7701353A 7701354A 7701355A 7701356A 7701382A 7701383A 7701384A 7701385A 7701402A 7701403A 7701404A 7701405A 7701419A 7701420A 7701422A 7701423A 7701424A 7701425A 7701426A 7701427A 7701430A 7701432A 7701433A 7701448A 7701449A 7701450A 7701451A 7701454A 7701455A 7701471B 7701557A 7701558A 7701559A 7701583A 7701584A 7701585A 7701586A 7701587A 7701588A 7701614A 7701615A 7701616A 7701621A 7701637A 7701638A 7701639A 7701652A 7701653A 7701654A 7701655A 7701656A 7701657A 7701658A 7701664A 7701665A 7701666A 7701667A 7701668A 7701669A 7701670A 7701680A 7701613A 7701699A 7701700A 7701701A 7701714A 7701715A 7701716A 7701717A 7701718A 7701719A 7701720A 7701721A 7701781A 7701782A 7701783A 7701784A 7701796A 7701926A 7701927A 7701937A 7701938A 7701939A 7701940A 7701941A 7702004A 7702005A 7702006A 7702007A 7702008A 7702009A 7702010A 7702011A 7702013A 7702014A 7702068A 7702222A 7702223A 7702224A 7702230A 7702231A 7702232A 7702233A 7702242B 7702243A 7702244A 7702245A 7702246A 7702247A 7702248A 7702249A 7702250A 7702251A 7702252A 7702291A 7702292A 7702293A 7702302A 7702303A 7702304A 7702305A 7702306A 7702307A 7702308A 7702309A 7702331A 7702332A 7702333A 7702334A 7702339A 7702340A 7702346A 7702353A 7702354A 7702355A 7702356A 7702376A 7702377A 7702378A 7702379A 7702390A 7702310A 7702411A 7702412A 7702490A 7702493A 7702494A 7702498A 7702499A 7702500A 7702501A 7702502A 7702503A 7702516A 7702517A 7702518A 7702519A 7702549A 7702550A 7702551A 7702552A 7702601A 7702602A 7702603A 7702604A 7702605A 7702606A 7702607A 7702608A 7702621A 7702622A 7702623A 7702655A 7702656A 7702657A 7702658A 7702741A 7702742A 7702743A 7702765A 7702766A 7702777A 7702778A 7702779A 7702780A 7702781A 7702782A 7702783A 7702784A 7702794A 7702795A 7702796A 7702797A 7702811A 7702812A 7702813A 7702814A 7702815A 7702816A 7702817A 7702818A 7702819A 7702820A 7702821A 7702822A 7702848A 7702849A 7702850A 7702856A 7702857A 7702861A 7702896A 7702897A 7702898A 7702899A 7702910A 7702911A 7702912A 7702913A 7702914A 7702915A 7702916A 7702924A 7702925A 7702926A 7702927A 7703060A 7703061A 7703062A 7703063A 7703064A 7703065A 7703066A 7703067A 7703068A 7703144A 7703145A 7703146A 7703147A 7703174A 7703175A 7703176A 7703177A 7703178A 7703179A 7703180A 7703181A 7703182A 7703183A 7703191A 7703192A 7703193A 7703194A 7703195A 7703236A 7703237A 7703238A 7703239A 7703240A 7703248A 7703249A 7703250A 7703251A 7703252A 7703253A 7703254A 7703255A 7703283A 7703284A 7703290A 7703291A 7703292A 7703293A 7703294A 7703295A 7703296A 7703318A 7703330A 7703331A 7703332A 7703333A 7703334A 7703347A 7703348A 7703349A 7703350A 7703351A 7703394A 7703395A 7703409A 7703491A 7703492A 7703493A 7703494A 7703495A 7703496A 7703497A 7703498A 7703499A 7703500A 7703501A 7703502A 7703503A 7703504A 7703635A 7703636A 7703637A 7703638A 7703775A 7703776A 7703777A 7703778A 7703779A 7703780A 7703781A 7703782A 7703783A 7703925A 7703926A 7703934A 7703935A 7703936A 7703937A 7703938A 7703939A 7703970A 7703971A 7703972A 7704003A 7704004A 7704098A 7704099A 7704100A 7704101A 7704102A 7704103A 7704104A 7704181A 7704182A 7704183A 7704184A 7704185A 7704186A 7704187A 7704188A 7704189A 7704190A 7704191A 7704192A 7704193A 7704297A 7704298A 7704299A 7704300A 7704301A 7704302A 7704327A 7704328A 7704329A 7704330A 7704331A 7704332A 7704333A 7704334A 7704408A 7704409A 7704410A 7704411A 7704412A 7704413A 7704419A 7704420A 7704421A 7704422A 7704423A 7704424A 7704425A 7704496A 7704497A 7704502A 7704503A 7704504A 7704505A 7704506A 7704507A 7704559A 7704560A 7704561A 7704562A 7704574A 7704575A 7704606A 7704607A 7704608A 7704649A 7704650A 7704651A 7704652A 7704653A 7704654A 7704655A 7704656A 7704657A 7704658A 7704659A 7704673A 7704674A 7704675A 7704676A 7704677A 7704678A 7704679A 7704735A … (truncated, 6158 characters total — see the official FDA record for the full value)
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20

CGMP Deviations: Presence of NDMA impurity detected in 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-0643-2020
Lot/product code:
7701069A 7701070A 7701084A 7701085A 7701087A 7701094A 7701095A 7701140A 7701141A 7701142A 7701157A 7701162A 7701182A 7701217A 7701218A 7701219A 7701236A 7701237A 7701220A 7701456A 7701470A 7701520A 7701671A 7701696A 7701697A 7701698A 7701797A 7701928A 7701929A 7701942A 7701943A 7702065A 7702066A 7702067A 7702095A 7702096A 7702097A 7702098A 7702188A 7702189A 7702190A 7702196A 7702197A 7702198A 7702199A 7702348A 7702338A 7702347A 7702349A 7702350A 7702391A 7702392A 7702546A 7702547A 7702548A 7702616A 7702617A 7702618A 7702619A 7702620A 7702763A 7702764A 7702851A 7702852A 7702853A 7702854A 7702855A 7702868A 7702869A 7702870A 7702871A 7702920A 7703054A 7703055A 7703056A 7703057A 7703058A 7703206A 7703208A 7703454A 7703455A 7703456A 7703486A 7703487A 7703488A 7703489A 7703490A 7703945A 7703946A 7703947A 7704111A 7704112A 7704113A 7704234A 7704235A 7704236A 7704237A 7704285A 7704286A 7704287A 7704288A 7704370A 7704371A 7704428A 7704429A 7704430A 7704431A 7704814A 7704838A 7704839A 7704840A 7704935A 7704936A 7704992A 7704996A 7704997A 7704998A 7704999A 7705037A 7705298A 7705299A 7705300A 7705301A 7705302A 7705303A 7705546A 7705584A 7705544A 7705545A 7705572A 7705585A 19190456 19190472 19190490 19191934 19191942 19191959 19192504
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
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

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)
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

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 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, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11

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-1353-2020
Lot/product code:
HF08618A 6/30/2020 HF08718A 6/30/2020 HF15418A 7/31/2020 HF15518A 7/31/2020 HH11818A 9/30/2020 HJ00818A 9/30/2020 HJ00918A 9/30/2020 HJ01018A 9/30/2020
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, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01

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-1348-2020
Lot/product code:
HF02318A 6/30/2020 HF02418A 6/30/2020 HF02518A 6/30/2020 HF07718A 6/30/2020 HH02118A 7/31/2020 HM04418A 12/31/2020 HM04518A 12/31/2020 HM04618A 12/31/2020 HM04718A 12/31/2020 HM05518A 12/31/2020 HM05618A 12/31/2020 HM05718A 12/31/2020 HM05818A 12/31/2020 HM05918A 12/31/2020 HM06018A 12/31/2020
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, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90

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-1393-2020
Lot/product code:
HB10019A 03-2021 HB10119A 03-2021 HB10219A 03-2021 HB10319A 03-2021 HD02119A 04-2021 HD03319A 04-2021 HF09118A 06-2020 HF11618A 06-2020 HF15218A 07-2020 HF15318A 07-2020 HJ01418A 09-2020 HJ01518A 09-2020 HJ01618A 09-2020 HJ01718A 09-2020 HJ04718A 09-2020 HK03218A 10-2020 HK03318A 10-2020 HK03418A 10-2020 HK03518A 10-2020 HK03618A 10-2020 HK13718A 11-2020 HK13818A 11-2020 HK13918A 11-2020 HK14018A 11-2020 HK14118A 11-2020 HK14218A 11-2020 HK14318A 11-2020 HK14418A 11-2020 HK14518A 11-2020 HM00118A 11-2020
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)
Class IIModerate risk
DrugRecalled May 29, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10

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-1347-2020
Lot/product code:
AM181118AA 10/31/2020 AM181191AA 9/30/2020 AM181192AA 9/30/2020 AM181235AA 9/30/2020 AM181236AA 9/30/2020 AM181237AA 9/30/2020 AM181240AA 9/30/2020 AM181241AA 9/30/2020 AM181242AA 9/30/2020 AM181243AA 9/30/2020 AM181244AA 10/31/2020 AM181268AA 10/31/2020 AM181269AA 10/31/2020 AM181270AA 10/30/2020 AM181271AA 10/31/2020 AM181272AA 10/31/2020 AM181273AA 10/31/2020 AM181274AA 10/31/2020 AM181275AA 10/31/2020 AM181276AA 10/31/2020 AM181277AA 10/31/2020 AM181307AA 10/31/2020 AM181308AA 10/31/2020 AM181309AA 10/31/2020 AM181310AA 10/31/2020 AM181311AA 10/31/2020 AM181313AA 10/31/2020 AM181314AA 10/31/2020 AM181315AA 11/30/2020 AM181316AA 11/30/2020 AM181317AA 12/31/2020 AM181419AA 11/30/2020 AM181420AA 11/30/2020 AM181421AA 11/30/2020 AM181422AA 11/30/2020 AM181423AA 11/30/2020 AM181424AA 11/30/2020 AM181425AA 11/30/2020 AM181430BA 12/31/2020 AM181455AA 12/31/2020 AM181456AA 12/31/2020 AM181457AA 12/31/2020 AM181458AA 12/31/2020 AM181459AA 12/31/2020 AM181460AA 12/31/2020 AM181461AA 12/31/2020 AM181462AA 12/31/2020 AM181463AA 12/31/2020 AM181464AA 12/31/2020 AM181465AA 12/31/2020 AM190054AA 12/31/2020 AM190055AA 12/31/2020 AM190057AA 12/31/2020 AM190058AA 12/31/2020 AM190102AA 12/31/2020 AM190103AA 12/31/2020 AM190104AA 12/31/2020 AM190105AA 12/31/2020 AM190106AA 12/31/2020 AM190107AA 12/31/2020 AM190108AA 12/31/2020 AM190120AA 12/31/2020 AM190633AA 5/31/2021 AM190634AA 5/31/2021 AM190635AA 5/31/2021 AM190636AA 5/31/2021 AM190637AA 5/31/2021 AM190638AA 5/31/2021 AM190640AA 5/31/2021 AM190641AA 5/31/2021 AM190642AA 5/31/2021 AM190664AA 5/31/2021 AM190665AA 5/31/2021 AM190666AA 5/31/2021 AM190667AA 5/31/2021 AM190668AA 5/31/2021 AM190669AA 6/30/2021 AM190670AA 6/30/2021 AM190671AA 6/30/2021 AM190672AA 6/30/2021 AM190714AA 6/30/2021 AM190934A 8/31/2021 AM190991A 8/31/2021 AM190992A 8/31/2021 AM190993A 8/31/2021 AM190994A 8/31/2021 AM191040A 9/30/2021 AM191041A 9/30/2021 AM191083A 9/30/2021 AM191084A 9/30/2021 AM191085A 9/30/2021 AM191091A 9/30/2021 AM191092A 9/30/2021 AM191105A 9/30/2021 AM191106A 10/31/2021 AM191107A 10/31/2021 AM191109A 10/31/2021 AM191186A 10/31/2021 AM191187A 10/31/2021 AM191188A 10/31/2021 AM191189A 10/31/2021 AM191190A 10/31/2021 AM191191A 10/31/2021 AM191192A 10/31/2021 AM191193A 10/31/2021 AM191194A 10/31/2021 AM191195A 10/31/2021 AM191244A 10/31/2021 AM191245A 10/31/2021 AM191246A 10/31/2021 AM191247A 10/31/2021 AM191294A 11/30/2021 AM191295A 11/30/2021 AM191296A 11/30/2021 AM191365A 11/30/2021 AM191366A 11/30/2021 AM191367A 11/30/2021 AM191392A 11/30/2021 AM191393A 11/30/2021 AM191394A 11/30/2021 AM191395A 12/31/2021 AM200001A 12/31/2021 AM200002A 12/31/2021 AM200003A 12/31/2021 AM200004A 12/31/2021 AM200005A 12/31/2021 AM200006A 12/31/2021 AM200045A 12/31/2021 AM200046A 12/31/2021 AM200047A 12/31/2021 AM200048A 12/31/2021 AM200049A 12/31/2021 AM200050A 12/31/2021 AM200051A 12/31/2021 AM200052A 12/31/2021 AM200053A 12/31/2021 AM200081A 12/31/2021 AM200082A 12/31/2021 AM200083 12/31/2021 AM200087A 12/31/2021 AM200088A 12/31/2021 AM200089 12/31/2021 AM200090 12/31/2021 AM200091 12/31/2021 AM200100 1/31/2022 AM200101 1/31/2022 AM200102 1/31/2022 AM200138 1/31/2022 AM200139 1/31/2022 AM200140 1/31/2022 AM200141 1/31/2022 AM200142 1/31/2022 AM200143 1/31/2022 AM200144 1/31/2022 AM200193 1/31/2022 AM200194 1/31/2022 AM200195 1/31/2022 AM200196 1/31/2022 AM200197 1/31/2022 AM200198 1/31/2022 AM200199 1/31/2022 AM200200 1/31/2022 AM200202 1/31/2022 AM200203 1/31/2022 AM200204 1/31/2022 AM200205 1/31/2022 AM200206 1/31/2022 AM200207 1/31/2022 AM200208 1/31/2022 AM200209 1/31/2022 AM200210 1/31/2022 AM200211 1/31/2022 AM200284 2/28/2022 AM200285 2/28/2022 AM200287 2/28/2022 AM200288 2/28/2022 AM200289 2/28/2022 AM200290 2/28/2022 AM200291 2/28/2022 AM200292 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, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05

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-1351-2020
Lot/product code:
HF06618A 6/30/2020 HF06718A 6/30/2020
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, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK

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-1354-2020
Lot/product code:
HA01520A 1/31/2021 HA01620A 1/31/2021 HG01719A 7/31/2020 HG01819A 7/31/2020 HH09319A 8/31/2020 HH09419A 9/30/2020 HK07619A 10/31/2020 HK07719A 10/31/2020
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, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10

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-1349-2020
Lot/product code:
AM181337A 10/31/2020 AM181338A 10/31/2020 AM181339A 11/30/2020 AM181340A 11/30/2020 AM181341A 11/30/2020 AM181342A 11/30/2020 AM181343A 11/30/2020 AM181344A 11/30/2020 AM181356A 11/30/2020 AM181357A 11/30/2020 AM181358A 11/30/2020 AM181359A 11/30/2020 AM181360A 11/30/2020 AM181361A 11/30/2020 AM181362A 11/30/2020 AM181363A 11/30/2020 AM181415A 11/30/2020 AM190040B 12/31/2020 AM190041A 12/31/2020 AM190042A 12/31/2020 AM190043A 12/31/2020 AM190044A 12/31/2020 AM190045A 12/31/2020 AM190046A 12/31/2020 AM190473B 4/30/2021 AM190474A 4/30/2021 AM190475A 4/30/2021 AM190476A 4/30/2021 AM190477A 4/30/2021 AM190478A 4/30/2021 AM190479A 4/30/2021 AM190480A 4/30/2021 AM190481A 4/30/2021 AM190482A 4/30/2021 AM190834A 7/31/2021 AM190835A 7/31/2021 AM190836A 7/31/2021 AM190837A 7/31/2021 AM190838A 7/31/2021 AM191004A 8/31/2021 AM191005A 8/31/2021 AM191006A 8/31/2021 AM191007A 8/31/2021 AM191008A 9/30/2021 AM191271A 10/31/2021 AM191272A 10/31/2021 AM191273A 10/31/2021 AM191274A 10/31/2021 AM191338A 11/30/2021 AM191339A 11/30/2021 AM191340A 11/30/2021 AM191341 12/31/2021 AM191342 12/31/2021 AM200109 12/31/2021 AM200110 12/31/2021 AM200111 12/31/2021
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, 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, 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, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10

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-1352-2020
Lot/product code:
HF08618A 6/30/2020 HF08718A 6/30/2020 HF15418A 7/31/2020 HF15518A 7/31/2020 HH11818A 9/30/2020 HJ00818A 9/30/2020 HJ00918A 9/30/2020 HJ01018A 9/30/2020
Recalling firm:
Amneal Pharmaceuticals of New York, LLC
View official FDA record (opens in a new tab)