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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/Prescription Drugs

Glenmark Pharmaceuticals Inc., USA: Clobetasol Propionate Foam Recalled Due to Defective Delivery System

Agency Publication Date: December 10, 2019
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Summary

Approximately 52,171 units of Clobetasol Propionate Foam (0.05%), including both standard and emulsion formulations, have been recalled. This prescription topical medication, manufactured by Glenmark Pharmaceuticals, is being recalled because the delivery system is defective, causing the product to come out as a liquid or fail to foam entirely. Consumers should contact their healthcare provider or pharmacist regarding this recall and for guidance on alternative treatments.

Risk

The defective delivery system prevents the medication from dispensing as the required foam, resulting in a liquid consistency that may affect how the drug is applied to the skin or the dosage administered. While the risk level is low, a failing delivery system can prevent the patient from receiving the medication in its intended form.

What You Should Do

  1. Check your prescription bottle or packaging for the product name 'Clobetasol Propionate Foam, 0.05%' or 'Clobetasol Propionate Foam (Emulsion Formulation), 0.05%' and look for NDC numbers 68462-608-27 (50g), 68462-608-94 (100g), 68462-625-27 (50g), or 68462-625-94 (100g).
  2. If you have the 68462-608 series, check for lot numbers 14190026, 14190028, 14190029 (Exp Feb-2021), 14190043, 14190045 (Exp Apr-2021), 14190024, 14190025, 14190027 (Exp Feb-2021), 14190030, 14190031 (Exp Mar-2021), 14190039, 14190042 (Exp Apr-2021), 14190047 (Exp May-2021), or 14190062 (Exp Jul-2021).
  3. If you have the 68462-625 Emulsion series, check for lot number 14190067 with an expiration date of July 2021.
  4. Contact your healthcare provider or pharmacist for guidance if your product is failing to foam or if you are concerned about your treatment.
  5. Return any unused or defective product to your pharmacy for a refund and contact Glenmark Pharmaceuticals Inc., USA at their Mahwah, NJ location for further instructions.
  6. For additional information or to report adverse events, 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 Foam, 0.05% (50 g pack)
Model:
NDC 68462-608-27
Lot Numbers:
14190026 (Exp Feb-2021)
14190028 (Exp Feb-2021)
14190029 (Exp Feb-2021)
14190043 (Exp Apr-2021)
14190045 (Exp Apr-2021)
Date Ranges: Feb-2021, Apr-2021
Product: Clobetasol Propionate Foam, 0.05% (100 g pack)
Model:
NDC 68462-608-94
Lot Numbers:
14190024 (Exp Feb-2021)
14190025 (Exp Feb-2021)
14190027 (Exp Feb-2021)
14190030 (Exp Mar-2021)
14190031 (Exp Mar-2021)
14190039 (Exp Apr-2021)
14190042 (Exp Apr-2021)
14190047 (Exp May-2021)
14190062 (Exp Jul-2021)
Date Ranges: Feb-2021, Mar-2021, Apr-2021, May-2021, Jul-2021
Product: Clobetasol Propionate Foam (Emulsion Formulation), 0.05% (50 g pack)
Model:
NDC 68462-625-27
Lot Numbers:
14190067 (Exp Jul-2021)
Date Ranges: Jul-2021
Product: Clobetasol Propionate Foam (Emulsion Formulation), 0.05% (100 g pack)
Model:
NDC 68462-625-94
Lot Numbers:
14190067 (Exp Jul-2021)
Date Ranges: Jul-2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84282
Status: Resolved
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2 products (a) 34521 bottles; b) 16930 bottles; a) 480 packs; b) 240 packs)
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.