Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Glenmark Pharmaceuticals Inc., USA
Reason for Recall:
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99

Product Codes/Lot Numbers:

Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0532-2024

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