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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 1,381–1,400 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28

by AvKARE

Reason
Labeling: Label Mix-Up
Recall initiated
October 18, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass III

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets

by Zydus Pharmaceuticals (USA) Inc

Reason
Labeling: Not Elsewhere Classified - Wrong NDC number
Recall initiated
November 14, 2024
Reported by FDA
December 11, 2024
Distribution
USA Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

by Amerisource Health Services LLC

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Recall initiated
November 14, 2024
Reported by FDA
December 11, 2024
Distribution
PA, OH, PR

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories

by Amerisource Health Services LLC

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Recall initiated
November 14, 2024
Reported by FDA
December 11, 2024
Distribution
PA, OH, PR

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06

by Amerisource Health Services LLC

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Recall initiated
November 14, 2024
Reported by FDA
December 11, 2024
Distribution
PA, OH, PR

View recall →

Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated
November 1, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated
November 1, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated
November 1, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated
November 1, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated
November 1, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated
November 1, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670

by Midlab Incorporated

Reason
cGMP Deviations: Out of specification results for micro in hand soap products.
Recall initiated
November 6, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339

by Midlab Incorporated

Reason
cGMP Deviations: Out of specification results for micro in hand soap products.
Recall initiated
November 6, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139

by Midlab Incorporated

Reason
cGMP Deviations: Out of specification results for micro in hand soap products.
Recall initiated
November 6, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509

by Midlab Incorporated

Reason
cGMP Deviations: Out of specification results for micro in hand soap products.
Recall initiated
November 6, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015

by Midlab Incorporated

Reason
cGMP Deviations: Out of specification results for micro in hand soap products.
Recall initiated
November 6, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303

by Midlab Incorporated

Reason
cGMP Deviations: Out of specification results for micro in hand soap products.
Recall initiated
November 6, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com

by Boulla LLC

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Recall initiated
November 4, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass I

ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com

by Boulla LLC

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Recall initiated
November 4, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass I

PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com

by Boulla LLC

Reason
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Recall initiated
November 4, 2024
Reported by FDA
December 11, 2024
Distribution
Nationwide within the United States

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.