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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

Glenmark Pharmaceuticals Inc., USA: Clotrimazole and Betamethasone Cream Recalled for Liquidy Texture

Agency Publication Date: August 15, 2019
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Summary

Glenmark Pharmaceuticals Inc., USA has recalled 31,224 tubes of Clotrimazole and Betamethasone Dipropionate Cream USP (1%/0.05%), a prescription topical medication. The recall was initiated after receiving complaints that the cream had a liquidy texture, indicating the product has been affected by temperature abuse during the supply chain or storage. This texture change means the medication may not have the correct consistency or stability intended for effective treatment. Consumers who have this prescription cream should check their tube for the affected lot number and contact their healthcare provider or pharmacist.

Risk

The liquidy texture of the cream suggests the product was exposed to temperatures outside of its required storage range, which can compromise the medication's physical stability and potentially its effectiveness in treating skin conditions.

What You Should Do

  1. Check your prescription tube of Clotrimazole and Betamethasone Dipropionate Cream USP (1%/0.05%), 15 grams, for lot number 05180734 with an expiration date of 03/2020.
  2. Verify the National Drug Code (NDC) 68462-298-17 is printed on the packaging to confirm it is the affected product.
  3. If your cream matches the affected lot number, contact your healthcare provider or pharmacist for guidance on continuing your treatment.
  4. Return any unused portions of the affected medication to your pharmacy for a refund and to ensure proper disposal.
  5. Contact Glenmark Pharmaceuticals Inc., USA for further instructions regarding this recall.
  6. For additional information or to report a safety concern, 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 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: Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (15 gram tubes)
Model:
NDC 68462-298-17
Recall #: D-1743-2019
Lot Numbers:
05180734 (Exp. 03/2020)
Date Ranges: Exp. 03/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83526
Status: Resolved
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Manufactured In: India, United States
Units Affected: 31,224 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.