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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Glenmark Pharmaceuticals Inc., USA: Mometasone Furoate Cream Recalled Due to Gritty Texture

Agency Publication Date: February 1, 2018
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Summary

Glenmark Pharmaceuticals Inc., USA is recalling 5,136 tubes of Mometasone Furoate Cream, USP, 0.1% (45 g). This prescription topical medication is being recalled because of quality deviations that resulted in consumer complaints about a "gritty texture" in the cream. While this is a voluntary recall initiated by the firm, using a product with an improper texture may affect how the medication is absorbed or cause localized irritation.

Risk

The gritty texture indicates a deviation from standard manufacturing practices, which can compromise the consistency and performance of the medication on the skin. No specific injuries have been reported, but the defect may lead to skin irritation or reduced effectiveness of the treatment.

What You Should Do

  1. Check your medicine cabinet for Glenmark Mometasone Furoate Cream, USP, 0.1% in 45 g tubes.
  2. Verify if your product is affected by looking for Batch Number 05170598 and an expiration date of 03/19 (March 2019) printed on the tube or carton.
  3. Identify the product further by checking the NDC number 68462019255 and the UPC barcode 3684620192559.
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and to discuss alternative treatments.
  5. Return any unused or affected tubes to the pharmacy or place of purchase for a refund.
  6. Contact Glenmark Pharmaceuticals Inc., USA at their Mahwah, New Jersey office for further instructions regarding this recall.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Return for refund and medical consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Glenmark Mometasone Furoate Cream, USP, 0.1% (45 g)
Model:
NDC 68462019255
UPC Codes:
3684620192559
Lot Numbers:
05170598 (Exp. 03/19)
Date Ranges: Expiration Date: 03/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78605
Status: Resolved
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 5136 tubes
Distributed To: Nationwide

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 · 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.