Public Health Trace

Get Alerts

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.

Filters

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 →

Drug Recall Ongoing Historical recordClass III

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30

by Alembic Pharmaceuticals Limited

Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Recall initiated: October 10, 2025
Reported by FDA: November 26, 2025
Distribution: Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01

by Aero Healthcare

Reason: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Recall initiated: October 17, 2025
Reported by FDA: November 12, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.

by Zydus Pharmaceuticals (USA) Inc

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Recall initiated: October 22, 2025
Reported by FDA: November 12, 2025
Distribution: Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

by Zydus Pharmaceuticals (USA) Inc

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Recall initiated: October 22, 2025
Reported by FDA: November 12, 2025
Distribution: Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

by Zydus Pharmaceuticals (USA) Inc

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Recall initiated: October 22, 2025
Reported by FDA: November 12, 2025
Distribution: Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.

by Teva Pharmaceuticals USA, Inc

Reason: Subpotent drug; Clavulanate Potassium component
Recall initiated: October 13, 2025
Reported by FDA: November 12, 2025
Distribution: Distributed in three (3) States: MS, OH, CA.

View recall →

Drug Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Recall initiated: October 28, 2025
Reported by FDA: November 5, 2025
Distribution: U.S Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

by Heritage Pharmaceuticals Inc

Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Recall initiated: October 6, 2025
Reported by FDA: November 5, 2025
Distribution: U.S. Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Recall initiated: October 28, 2025
Reported by FDA: November 5, 2025
Distribution: U.S Nationwide.

View recall →

Data last updated: September 6, 2026 ET

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.