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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 781–800 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211

by Private Label Skin Care Inc.

Reason
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Recall initiated
September 12, 2025
Reported by FDA
October 1, 2025
Distribution
CA, GA only

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Drug Recall Ongoing Historical recordClass II

ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210

by Private Label Skin Care Inc.

Reason
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Recall initiated
September 12, 2025
Reported by FDA
October 1, 2025
Distribution
CA, GA only

View recall →

Drug Recall Ongoing Historical recordClass II

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Market complaints received for gritty texture (grainy)
Recall initiated
September 17, 2025
Reported by FDA
October 1, 2025
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14

by Consumer Product Partners, LLC

Reason
Cross Contamination with Other Products.
Recall initiated
August 25, 2025
Reported by FDA
October 1, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass III

Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14

by Consumer Product Partners, LLC

Reason
Cross Contamination with Other Products.
Recall initiated
August 25, 2025
Reported by FDA
October 1, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.

by YANGZHOU YULOU PAPER PRODUCTS CO., LTD

Reason
cGMP Deviations
Recall initiated
July 21, 2025
Reported by FDA
October 1, 2025
Distribution
N/A

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Drug Recall Ongoing Historical recordClass II

Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Recall initiated
September 3, 2025
Reported by FDA
September 24, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurity/Degradation Specifications
Recall initiated
September 4, 2025
Reported by FDA
September 24, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurity/Degradation Specifications
Recall initiated
September 4, 2025
Reported by FDA
September 24, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass I

Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.

by Unichem Pharmaceuticals USA Inc.

Reason
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Recall initiated
August 27, 2025
Reported by FDA
September 24, 2025
Distribution
Nationwide within the U.S.A

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Drug Recall Ongoing Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.

by Northwind Pharmaceuticals LLC

Reason
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 20, 2025
Reported by FDA
September 24, 2025
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Recall initiated
August 26, 2025
Reported by FDA
September 24, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Recall initiated
August 26, 2025
Reported by FDA
September 24, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.

by Sandoz Inc

Reason
cGMP deviations: Temperature excursion during transportation.
Recall initiated
September 5, 2025
Reported by FDA
September 24, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)

by Amerisource Health Services LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 27, 2025
Reported by FDA
September 24, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)

by Amerisource Health Services LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 27, 2025
Reported by FDA
September 24, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)

by Amerisource Health Services LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 27, 2025
Reported by FDA
September 24, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.

by Amerisource Health Services LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 27, 2025
Reported by FDA
September 24, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility
Recall initiated
August 29, 2025
Reported by FDA
September 24, 2025
Distribution
USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03

by Ascend Laboratories, LLC

Reason
Superpotent drug
Recall initiated
August 28, 2025
Reported by FDA
September 24, 2025
Distribution
Nationwide in the USA.

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.