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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 Clotrimazole and Betamethasone Cream Recalled for Assay Failure

Agency Publication Date: March 29, 2022
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Summary

Taro Pharmaceuticals U.S.A., Inc. has recalled 768 tubes of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (15 g tubes). This prescription antifungal and steroid cream is used to treat fungal skin infections. The recall was issued because testing of a stability sample showed inconsistent levels of Betamethasone Dipropionate (the steroid component), meaning the product failed content uniformity specifications.

Risk

Inconsistent levels of the active steroid ingredient could lead to the medication being less effective than intended or having a different potency than prescribed. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects 15 g tubes of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (NDC 51672-4048-1) under the Taro brand.
  2. Identify affected tubes by checking for lot number AC33883 with an expiration date of June 2023 printed on the tube or carton.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (15 g tubes)by Taro
Variants: 15 g tubes, 1%/0.05%, Rx only
Lot Numbers:
AC33883 (Exp June 2023)
NDC:
51672-4048-1

Quantity: 768 tubes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89678
Status: Resolved
Manufacturer: Taro Pharmaceuticals U.S.A., Inc.
Sold By: Retail consignee
Manufactured In: Israel, United States
Units Affected: 768 tubes
Distributed To: New York

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.