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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 1,261–1,280 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), 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

Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), 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

Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01

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

Lacosamide Tablets, 100mg , 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# 68462-679-60

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

Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-325-60

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

Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.

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

Fluphenazine Hydrochloride Tablets 2.5mg, 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# 68462-336-01

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

Fluphenazine Hydrochloride Tablets, 10mg, 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# 68462-338-01

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

Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.

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

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 →

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.

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