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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 6,041–6,060 of 17,964 drug recalls

Drug Recall Ongoing Historical recordClass II

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

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
May 29, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12

by Pfizer Inc.

Reason
Failed Dissolution Specifications
Recall initiated
May 27, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.

by Alembic Pharmaceuticals Limited

Reason
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Recall initiated
June 10, 2020
Reported by FDA
July 1, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15

by Crown Laboratories

Reason
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Recall initiated
June 10, 2020
Reported by FDA
July 1, 2020
Distribution
Distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30

by Crown Laboratories

Reason
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Recall initiated
June 10, 2020
Reported by FDA
July 1, 2020
Distribution
Distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097

by A.P. Deauville, LLC

Reason
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Recall initiated
June 3, 2020
Reported by FDA
July 1, 2020
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350

by QuVa Pharma, Inc.

Reason
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Recall initiated
April 23, 2020
Reported by FDA
July 1, 2020
Distribution
Distributed Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
June 11, 2020
Reported by FDA
July 1, 2020
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127

by PD-Rx Pharmaceuticals, Inc.

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
June 5, 2020
Reported by FDA
July 1, 2020
Distribution
United States.

View recall →

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
June 2, 2020
Reported by FDA
July 1, 2020
Distribution
Product was distributed throughout the United States, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
June 2, 2020
Reported by FDA
July 1, 2020
Distribution
Product was distributed throughout the United States, including Puerto Rico.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.