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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 Azelaic Acid Gel Recalled for Manufacturing Deviations

Agency Publication Date: July 29, 2024
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Summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling 14,004 cartons of Glenmark Azelaic Acid Gel, 15 % (50 grams) due to Current Good Manufacturing Practice (CGMP) deviations. This prescription medication is used to treat skin conditions, and the recall affects specific units distributed nationwide. Consumers should consult with their healthcare provider or pharmacist regarding the use of this medication.

Risk

The recall was initiated because the product was manufactured under conditions that did not meet strict quality control standards, which may compromise the product's safety, identity, strength, or quality.

What You Should Do

  1. This recall affects Glenmark Azelaic Acid Gel, 15 % (50 grams) packaged in 50-gram cartons with NDC 68462-626-52, identifying lot number 19241453 and an expiration date of March 2026.
  2. 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 Glenmark Pharmaceuticals Inc., USA for further instructions.
  3. 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: Glenmark Azelaic Acid Gel, 15 % (50 grams)by Glenmark
Variants: 15 %, 50 grams, Gel
Lot Numbers:
19241453 (Exp MARCH 2026)
NDC:
68462-626-52

Recall #: D-0621-2024; Total quantity: 14,004 cartons

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95022
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Manufactured In: India
Units Affected: 14,004 cartons
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 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.