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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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Drug Recall Terminated Historical recordClass II

RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated: November 17, 2020
Reported by FDA: December 23, 2020
Distribution: Distributed Nationwide in the USA and Canada

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Drug Recall Terminated Historical recordClass II

Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated: November 17, 2020
Reported by FDA: December 23, 2020
Distribution: Distributed Nationwide in the USA and Canada

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Drug Recall Terminated Historical recordClass II

Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated: November 17, 2020
Reported by FDA: December 23, 2020
Distribution: Distributed Nationwide in the USA and Canada

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Drug Recall Terminated Historical recordClass II

Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated: November 17, 2020
Reported by FDA: December 23, 2020
Distribution: Distributed Nationwide in the USA and Canada

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Drug Recall Terminated Historical recordClass II

H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated: November 17, 2020
Reported by FDA: December 23, 2020
Distribution: Distributed Nationwide in the USA and Canada

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Drug Recall Terminated Historical recordClass II

Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716.

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated: November 17, 2020
Reported by FDA: December 23, 2020
Distribution: Distributed Nationwide in the USA and Canada

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Drug Recall Terminated Historical recordClass II

CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated: November 17, 2020
Reported by FDA: December 23, 2020
Distribution: Distributed Nationwide in the USA and Canada

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Drug Recall Completed Historical recordClass II

Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden

by BASF Corporation

Reason: Cross contamination: the excipient was found to be contaminated with theophylline.
Recall initiated: November 17, 2020
Reported by FDA: December 23, 2020
Distribution: USA Nationwide and Worldwide

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Drug Recall Terminated Historical recordClass II

Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01

by Biogen MA Inc.

Reason: Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Recall initiated: December 9, 2020
Reported by FDA: December 23, 2020
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass III

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

by SCA Pharmaceuticals

Reason: Subpotency: Out-of-specification stability test result for low potency was obtained.
Recall initiated: November 20, 2020
Reported by FDA: December 23, 2020
Distribution: Product was distributed to three hospitals in MO & LA.

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Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specifications
Recall initiated: December 3, 2020
Reported by FDA: December 23, 2020
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specifications
Recall initiated: December 3, 2020
Reported by FDA: December 23, 2020
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

View recall →

Data last updated: September 14, 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.