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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 1,121–1,140 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-639-45.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-681-60.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-572-30.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-573-30

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-409-60

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-580-01

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
March 13, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1

by ASEGUA THERAPEUTICS LLC

Reason
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Recall initiated
March 7, 2025
Reported by FDA
April 16, 2025
Distribution
US Nationwide

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Drug Recall Ongoing Historical recordClass III

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Cross Contamination
Recall initiated
March 4, 2025
Reported by FDA
April 16, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Cross Contamination
Recall initiated
March 4, 2025
Reported by FDA
April 16, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass II

Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.

by Zydus Pharmaceuticals (USA) Inc

Reason
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Recall initiated
March 21, 2025
Reported by FDA
April 16, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Recall initiated
March 11, 2025
Reported by FDA
April 9, 2025
Distribution
Nationwide in the USA and PR

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Recall initiated
March 26, 2025
Reported by FDA
April 9, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.

by Amerisource Health Services LLC

Reason
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Recall initiated
March 24, 2025
Reported by FDA
April 9, 2025
Distribution
USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13

by BIOCON PHARMA INC

Reason
Failed dissolution specifications: lower than specifications
Recall initiated
March 17, 2025
Reported by FDA
April 9, 2025
Distribution
U.S.A. nationwide

View recall →

Drug Recall Ongoing Historical recordClass III

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.

by Imprimis NJOF, LLC

Reason
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Recall initiated
February 24, 2025
Reported by FDA
April 9, 2025
Distribution
FL and NY

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.