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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 741–760 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Recall initiated
October 23, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90

by Golden State Medical Supply Inc.

Reason
Failed Dissolution Specifications
Recall initiated
October 20, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05

by Imprimis NJOF, LLC

Reason
Subpotent Drug
Recall initiated
October 20, 2025
Reported by FDA
November 26, 2025
Distribution
USA 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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