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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 1,241–1,260 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

by B. Braun Medical Inc

Reason
Presence of Particulate Matter
Recall initiated
March 31, 2025
Reported by FDA
April 16, 2025
Distribution
Product was distributed to 12 distributors who may have further distributed the product nationwide.

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Drug Recall Ongoing Historical recordClass II

Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), 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

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Drug Recall Ongoing Historical recordClass II

Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Lacosamide Tablets 150mg, 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# 68462-680-60.

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 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# 68462-562-01

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), 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

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Drug Recall Ongoing Historical recordClass II

Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18

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

Rosuvastatin Tablets 40mg, 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# 68462-264-30

by Glenmark Pharmaceuticals Inc., USA

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

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Drug Recall Ongoing Historical recordClass II

Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01

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, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60

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

Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05.

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

Ranolazine Extended-Release Tablets 1000mg, 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# 68462-320-60

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

Teriflunomide Tablets, 14mg, 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# 68462-424-30

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 →

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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