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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 5,741–5,760 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass III

Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310

by Teligent Pharma, Inc.

Reason
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Recall initiated
September 28, 2020
Reported by FDA
November 11, 2020
Distribution
United States Nationwide

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Drug Recall Terminated Historical recordClass II

Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01

by Marksans Pharma Limited

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
October 2, 2020
Reported by FDA
November 11, 2020
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50

by Marksans Pharma Limited

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
October 2, 2020
Reported by FDA
November 11, 2020
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60

by PD-Rx Pharmaceuticals, Inc.

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recall initiated
October 6, 2020
Reported by FDA
November 11, 2020
Distribution
AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI

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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 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

by PD-Rx Pharmaceuticals, Inc.

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recall initiated
October 6, 2020
Reported by FDA
November 11, 2020
Distribution
AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI

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Drug Recall Terminated Historical recordClass II

Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90

by Direct Rx

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recall initiated
October 12, 2020
Reported by FDA
November 11, 2020
Distribution
FL

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Drug Recall Ongoing Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131

by Denton Pharma, Inc.

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recall initiated
October 8, 2020
Reported by FDA
November 11, 2020
Distribution
Indiana - Nationwide.

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Drug Recall Ongoing Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30

by Denton Pharma, Inc.

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recall initiated
October 8, 2020
Reported by FDA
November 11, 2020
Distribution
Indiana - Nationwide.

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Drug Recall Terminated Historical recordClass II

Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0

by Medichem S.A.

Reason
Discoloration.
Recall initiated
October 2, 2020
Reported by FDA
November 11, 2020
Distribution
AL, NJ, TX

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Drug Recall Terminated Historical recordClass II

N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023

by Jarrow Formulas Inc

Reason
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
Recall initiated
October 9, 2020
Reported by FDA
November 4, 2020
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15

by Bausch Health Companies, Inc.

Reason
SUBPOTENT DRUG
Recall initiated
July 13, 2020
Reported by FDA
November 4, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
An extraneous peak was observed for dissolution testing.
Recall initiated
October 5, 2020
Reported by FDA
November 4, 2020
Distribution
Distributed Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
An extraneous peak was observed for dissolution testing.
Recall initiated
October 5, 2020
Reported by FDA
November 4, 2020
Distribution
Distributed Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
An extraneous peak was observed for dissolution testing.
Recall initiated
October 5, 2020
Reported by FDA
November 4, 2020
Distribution
Distributed Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00

by RemedyRePack Inc.

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recall initiated
October 11, 2020
Reported by FDA
November 4, 2020
Distribution
Product was distributed to one customer in PA.

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Drug Recall Terminated Historical recordClass III

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

by Mylan Pharmaceuticals Inc.

Reason
Out-of-specification organic impurity results obtained during routine stability testing.
Recall initiated
October 2, 2020
Reported by FDA
October 28, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10

by ANI Pharmaceuticals, Inc.

Reason
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Recall initiated
October 9, 2020
Reported by FDA
October 28, 2020
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10

by ANI Pharmaceuticals, Inc.

Reason
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Recall initiated
October 9, 2020
Reported by FDA
October 28, 2020
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10

by ANI Pharmaceuticals, Inc.

Reason
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Recall initiated
October 9, 2020
Reported by FDA
October 28, 2020
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10

by ANI Pharmaceuticals, Inc.

Reason
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Recall initiated
October 9, 2020
Reported by FDA
October 28, 2020
Distribution
Distributed Nationwide in the USA

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.