Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Divalproex Sodium Extended Release Tablets Recalled by Amneal Pharmaceuticals of New York, LLC Due to Failed dissolution specifications.

Date: July 27, 2022
Company: Amneal Pharmaceuticals of New York, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amneal Pharmaceuticals of New York, LLC directly.

Affected Products

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

Quantity: 4,309 bottles

Why Was This Recalled?

Failed dissolution specifications.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Amneal Pharmaceuticals of New York, LLC

Amneal Pharmaceuticals of New York, LLC has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report