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 MAJOR PHARMACEUTICALS Due to cGMP deviations: Product was exposed above 50% relative...

Date: April 24, 2019
Company: MAJOR PHARMACEUTICALS
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 MAJOR PHARMACEUTICALS directly.

Affected Products

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.

Quantity: 828 100-count unit dose cartons

Why Was This Recalled?

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MAJOR PHARMACEUTICALS

MAJOR PHARMACEUTICALS has 7 total recalls tracked by RecallDetector.

Related Recalls

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