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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 Rizatriptan Benzoate Tablets Recalled for Excessive Impurities

Agency Publication Date: June 4, 2024
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Summary

Glenmark Pharmaceuticals Inc., USA has recalled 15,456 cartons of Rizatriptan Benzoate Tablets USP (rizatriptan benzoate), a medication used to treat migraine headaches. The recall includes both 5 mg and 10 mg strengths in unit-dose packages of 18 tablets. Testing discovered that the medication contains an impurity called N-Nitroso Desmethyl Rizatriptan at levels that are higher than the safety limits established by the FDA.

Risk

The tablets contain a nitrosamine impurity at levels exceeding the FDA's acceptable limit. While no immediate health issues have been reported, long-term exposure to certain nitrosamines above safety thresholds may increase the risk of developing cancer.

What You Should Do

  1. The recalled products are Glenmark Rizatriptan Benzoate Tablets USP (5 mg and 10 mg) sold in 18 (3 X 6) unit-dose tablet cartons. Affected 5 mg cartons (NDC 68462-465-99) feature lot numbers 19233788 (Exp. 9/2025) and 19224445 (Exp. 9/2024). Affected 10 mg cartons (NDC 68462-466-99) feature lot numbers 19224217 (Exp. 9/2024), 19233789 (Exp. 9/2025), and 19224444 (Exp. 9/2024).
  2. If you have health concerns about having taken this medication, 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.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

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: Rizatriptan Benzoate Tablets USP, 5mg (18 Unit-Dose Tablets)
Variants: 5 mg, Tablet
Lot Numbers:
19233788 (Exp. 9/2025)
19224445 (Exp. 9/2024)
NDC:
68462-465-99

Recall #: D-0532-2024

Product: Rizatriptan Benzoate Tablets USP, 10 mg (18 Unit-Dose Tablets)
Variants: 10 mg, Tablet
Lot Numbers:
19224217 (Exp. 9/2024)
19233789 (Exp. 9/2025)
19224444 (Exp. 9/2024)
NDC:
68462-466-99

Recall #: D-0533-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94606
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Pharmacies
Manufactured In: India
Units Affected: 2 products (3,480 cartons; 11,976 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.