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  5. FDA Recall: Memantine Hydrochloride

FDA Recall Memantine Hydrochloride

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Memantine Hydrochloride with NDC 0904-6737 was initiated on 04-24-2020 as a Class III recall due to failed dissolution specifications: low stage 3 results obtained for dissolution during routine stability testing. The latest recall number for this product is D-1262-2020 and the recall is currently terminated as of 08-19-2022 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1262-202004-24-202005-20-2020Class III678 cartonsMemantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61Terminated
D-0844-202012-13-201902-26-2020Class III246 CartonsMemantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61Terminated

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.