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  5. FDA Recall: Rizatriptan Benzoate

FDA Recall Rizatriptan Benzoate

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Rizatriptan Benzoate with NDC 68462-466 was initiated on 05-10-2024 as a Class II recall due to cgmp deviations: n-nitroso desmethyl rizatriptan impurity results that are above the fda acceptable limit. The latest recall number for this product is D-0533-2024 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0533-202405-10-202406-12-2024Class II11,976 cartonsRizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99Ongoing
D-0532-202405-10-202406-12-2024Class II3,480 cartonsRizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99Ongoing

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.