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.

Unit Dose Valsartan Tablets Recalled by MAJOR PHARMACEUTICALS Due to CGMP Deviations: Carcinogen impurity detected in API used...

Date: July 18, 2018
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

Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.

Quantity: 5,464 cartons

Why Was This Recalled?

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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