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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Clobetasol Propionate Ointment Recalled for Bacterial Contamination

Agency Publication Date: January 11, 2022
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Summary

Taro Pharmaceuticals U.S.A., Inc. has recalled 96 tubes of Clobetasol Propionate Ointment USP, 0.05% in 60g tubes because the product may be contaminated with R. Pickettii bacteria. This bacterial contamination was discovered during routine testing of the product. No incidents or injuries related to this recall have been reported to date. This prescription ointment was distributed to wholesalers in Louisiana and Utah and may have been further distributed to retail pharmacies nationwide.

Risk

The presence of R. Pickettii bacteria in a topical ointment can cause serious skin or systemic infections, especially in individuals with weakened immune systems or preexisting skin conditions.

What You Should Do

  1. This recall affects 60g tubes of Clobetasol Propionate Ointment USP, 0.05% (NDC 51672-1259-3) from lot number AC13786 with an expiration date of December 2022.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
🗑️Option 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clobetasol Propionate Ointment USP, 0.05% (60g)
Variants: 60g tube, Rx only
UPC Codes:
351672125936
Lot Numbers:
AC13786 (Exp DEC 2022)
NDC:
51672-1259-3

Manufactured by Taro Pharmaceutical Industries Ltd. in Haifa Bay, Israel.

Product Images

Label, Taro Clobetasol Propionate

Label, Taro Clobetasol Propionate

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89241
Status: Resolved
Manufacturer: Taro Pharmaceuticals U.S.A., Inc.
Sold By: retail level
Manufactured In: Israel, United States
Units Affected: 96 tubes
Distributed To: Nationwide
Agency Last Updated: January 18, 2022

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 · FDA Press Release · 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.