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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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Low RiskFDA Drug
Medications & Supplements/Topical Products

Taro Pharmaceuticals U.S.A., Inc.: Clobetasol Propionate Cream Recalled for Failure to Meet Potency Standards

Agency Publication Date: February 1, 2018
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Summary

Approximately 27,792 tubes of Clobetasol Propionate Cream USP, 0.05% (60 g tubes) are being recalled because the medication failed content uniformity specifications. This means the active ingredient may not be evenly distributed throughout the cream, which can lead to some doses being too strong or too weak. This prescription-only topical steroid was distributed nationwide in 60-gram tubes.

Risk

Failure to meet uniformity standards means the medication may not provide the intended therapeutic effect or could potentially deliver an inconsistent dose of the steroid to the skin. While this recall is classified as low risk, using a product with improper ingredient distribution may affect the management of the skin condition being treated.

What You Should Do

  1. Check your medication tube for Clobetasol Propionate Cream USP, 0.05% in the 60 g size with NDC 51672-1258-3 and UPC 351672125837.
  2. Locate the lot number and expiration date on the crimp of the tube or the side of the carton to see if it matches Lot 311235 with an expiration date of September 2018.
  3. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to determine if a replacement is necessary.
  4. Return any unused portion of the affected product to your pharmacy for a refund.
  5. Contact Taro Pharmaceuticals U.S.A., Inc. at their Hawthorne, NY location or through their customer service channels for further instructions regarding this recall.
  6. For additional questions or to report a problem, 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

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Clobetasol Propionate Cream USP, 0.05% (60 g tube)
Model:
NDC 51672-1258-3
UPC Codes:
351672125837
Lot Numbers:
311235 (Exp Sept 2018)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79029
Status: Resolved
Manufacturer: Taro Pharmaceuticals U.S.A., Inc.
Manufactured In: United States, Israel
Units Affected: 27,792 tubes
Distributed To: Nationwide

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.