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 Delayed Release Tablets Recalled by Zydus Pharmaceuticals USA Inc Due to Failed Dissolution Specifications; 9 month long term stability

Date: March 15, 2017
Company: Zydus Pharmaceuticals USA Inc
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 Zydus Pharmaceuticals USA Inc directly.

Affected Products

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ

Quantity: 32628 bottles

Why Was This Recalled?

Failed Dissolution Specifications; 9 month long term stability

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zydus Pharmaceuticals USA Inc

Zydus Pharmaceuticals USA Inc has 41 total recalls tracked by RecallDetector.

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