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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 Failed Content Uniformity

Agency Publication Date: August 12, 2020
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Summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 7,632 tubes of Clobetasol Propionate Cream USP, 0.05%, because the bulk ingredient used to manufacture the product did not meet consistency and uniformity standards. This prescription topical medication is used for skin conditions and was sold in 15 g and 45 g tubes. Because the medication may not be evenly distributed throughout the cream, patients may receive a dose that is either too high or too low, potentially affecting the treatment's effectiveness or safety. Consumers should contact their healthcare provider or pharmacist to discuss alternatives and how to return the product.

Risk

The cream failed content uniformity testing, meaning the active ingredient may not be distributed evenly throughout the tube. This could lead to inconsistent dosing where some applications have too much medication and others have too little, potentially causing skin irritation or failing to treat the underlying condition effectively.

What You Should Do

  1. Check your prescription cream tubes for Clobetasol Propionate Cream USP, 0.05% with NDC codes 60429-902-15 (15 g) or 60429-902-45 (45 g).
  2. Verify the lot numbers and expiration dates on the tube crimp or carton: look for lot AB28353 (15 g) or lot AB40178 (45 g), both with an expiration date of 12/31/2021.
  3. If your product matches these lot numbers, contact your healthcare provider or pharmacist for guidance on your treatment and to obtain a replacement prescription if necessary.
  4. Return any unused portion of the recalled cream to your pharmacy for a refund and to ensure the product is disposed of properly.
  5. Contact Taro Pharmaceuticals U.S.A., Inc. at their distributor address (3 Skyline Dr, Hawthorne, NY) or through your dispensing pharmacy for further instructions.
  6. For additional questions or to report side effects, 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

Manufacturer refund through pharmacy

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% (15 g tube)
Model:
NDC: 60429-902-15
Lot Numbers:
AB28353 (Exp 12/31/2021)
Date Ranges: Expiration Date 12/31/2021
Product: Clobetasol Propionate Cream USP, 0.05% (45 g tube)
Model:
NDC: 60429-902-45
Lot Numbers:
AB40178 (Exp 12/31/2021)
Date Ranges: Expiration Date 12/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86101
Status: Resolved
Manufacturer: Taro Pharmaceuticals U.S.A., Inc.
Sold By: Golden State Medical Supply, Inc.; pharmacies
Manufactured In: Canada, United States
Units Affected: 7632 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.