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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Taro Pharmaceuticals U.S.A., Inc.: Clotrimazole Antifungal Creams Recalled Due to Impurity Levels

Agency Publication Date: December 11, 2020
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Summary

Taro Pharmaceuticals is voluntarily recalling 843,156 units of various brands of Clotrimazole Cream USP 1%, an antifungal medication used to treat conditions like athlete's foot, jock itch, and ringworm. The recall was initiated because an unknown impurity was detected in the product slightly above the allowed specification limit during shelf-life testing. These creams were sold under multiple brand names including CVS Health, Equate, H-E-B, Kaiser Permanente, Kroger, Rite Aid, Best Choice, and TopCare Health across the United States and Canada.

Risk

The presence of a degradation impurity above the required limit means the drug does not meet quality standards, which could potentially impact the effectiveness of the treatment or cause unexpected side effects during topical application.

What You Should Do

  1. Check your medicine cabinet for Clotrimazole Cream USP 1% antifungal products from brands including CVS Health, Equate (Walmart), H-E-B, Kaiser Permanente, Kroger, Rite Aid, Best Choice, TopCare Health, or Taro Pharmaceuticals.
  2. Verify if your product is affected by matching the lot number and expiration date on the tube or carton. Affected lots include: A873430336 (Exp Dec-2020), A873430371 (Exp Dec-2020), B870030918 (Exp Jan-2021), C868330918 (Exp Feb-2021), A873430406 (Exp Dec-2020), A873530406 (Exp Dec-2020), A873630406 (Exp Dec-2020), B870030635 (Exp Jan-2021), B870130867 (Exp Jan-2021), C868330867 (Exp Feb-2021), A873630558 (Exp Dec-2020), D867331276 (Exp Mar-2021), A873630634 (Exp Dec-2020), B870030634 (Exp Jan-2021), A873430372 (Exp Dec-2020), D867331278 (Exp Mar-2021), A873630557 (Exp Dec-2020), A873630559 (Exp Dec-2020), D867331087 (Exp Mar-2021), D867331277 (Exp Mar-2021), and B870130838 (Exp Jan-2021).
  3. Stop using any recalled cream immediately and contact your healthcare provider or pharmacist for guidance on alternative treatments.
  4. Return any unused recalled product to the pharmacy or retail store where it was purchased for a full refund.
  5. Contact Taro Pharmaceuticals U.S.A., Inc. at 1-888-723-3332 or visit www.taro.com for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Product return and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1% (1 oz)
Model:
NDC 59779-305-03
Lot Numbers:
A873430336 (Exp Dec-2020)
Date Ranges: Expiration Dec-2020
Product: Equate Athlete's Foot, Clotrimazole USP 1% (0.5 oz)
Model:
NDC 49035-812-01
Lot Numbers:
A873430371 (Exp Dec-2020)
B870030918 (Exp Jan-2021)
C868330918 (Exp Feb-2021)
Date Ranges: Expiration Dec-2020, Expiration Jan-2021, Expiration Feb-2021
Product: Equate Athlete's Foot, Clotrimazole USP 1% (2 oz)
Model:
NDC 49035-812-27
Lot Numbers:
A873430406 (Exp Dec-2020)
A873530406 (Exp Dec-2020)
A873630406 (Exp Dec-2020)
B870030635 (Exp Jan-2021)
B870130867 (Exp Jan-2021)
C868330867 (Exp Feb-2021)
Date Ranges: Expiration Dec-2020, Expiration Jan-2021, Expiration Feb-2021
Product: H-E-B Athlete's Foot Cream Clotrimazole Cream USP, 1% (0.5 oz)
Model:
NDC 37808-305-01
Lot Numbers:
A873630558 (Exp Dec-2020)
D867331276 (Exp Mar-2021)
Date Ranges: Expiration Dec-2020, Expiration Mar-2021
Product: Kaiser Permanente Clotrimazole Cream USP, 1% (1 oz)
Model:
NDC 0179-8014-30
Lot Numbers:
A873630634 (Exp Dec-2020)
B870030634 (Exp Jan-2021)
Date Ranges: Expiration Dec-2020, Expiration Jan-2021
Product: Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1% (0.5 oz)
Model:
NDC 30142-305-01
Lot Numbers:
A873430372 (Exp Dec-2020)
D867331278 (Exp Mar-2021)
Date Ranges: Expiration Dec-2020, Expiration Mar-2021
Product: Kroger Jock Itch Cream, Clotrimazole Cream USP, 1% (0.5 oz)
Model:
NDC 30142-510-01
Lot Numbers:
A873630557 (Exp Dec-2020)
Date Ranges: Expiration Dec-2020
Product: RiteAid Pharmacy Ringworm Cream, Clotrimazole Cream USP, 1% (0.5 oz)
Model:
UPC 0 11822 53812 1
UPC Codes:
011822538121
Lot Numbers:
A873630559 (Exp Dec-2020)
Date Ranges: Expiration Dec-2020
Product: Best Choice, Clotrimazole Cream, USP 1% (0.5 oz)
Model:
UPC 0-70038-20355-1
UPC Codes:
070038203551
Lot Numbers:
D867331087 (Exp Mar-2021)
Date Ranges: Expiration Mar-2021
Product: TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1% (0.5 oz)
Model:
NDC 36800-495-69
UPC 0 36800 49569 2
UPC Codes:
036800495692
Lot Numbers:
D867331277 (Exp Mar-2021)
Date Ranges: Expiration Mar-2021
Product: Athlete's Foot Cream, Clotrimazole Cream USP, 1% (1 oz)
Model:
UPC 3 51672 20022 0
UPC Codes:
351672200220
Lot Numbers:
B870130838 (Exp Jan-2021)
Date Ranges: Expiration Jan-2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86833
Status: Resolved
Manufacturer: Taro Pharmaceuticals U.S.A., Inc.
Sold By: CVS Pharmacy; Walmart; H-E-B; Kaiser Foundation Hospitals; Kroger; Rite Aid; Valu Merchandisers; Topco Associates
Manufactured In: United States, Canada
Units Affected: 8 products (64,692 1 oz tubes; 481,896 tubes; 30,816 1 oz tubes; 133,452 0.5 oz tubes; 45,396 units; 34,920 0.5 oz tubes; 11,088 1 oz tubes; 40,896 1 oz tube)
Distributed To: Nationwide
Agency Last Updated: December 16, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.