Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10

FDA recall notice · announced August 31, 2022 · Amneal Pharmaceuticals Of New York

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10

Reason for recall

Failed dissolution specifications.

Notes

Distribution: USA nationwide
Lot/code information: Lot #: AR210705, Exp 04/2024
Quantity: 4,309 bottles
Status: Terminated
Products in this recall event:
- Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, (D-1362-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.