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.

Losartan Potassium Tablets Recalled by MAJOR PHARMACEUTICALS Due to CGMP Deviations: FDA lab confirmed presence of an...

Date: January 10, 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

Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.

Quantity: 3,102 Cartons (310,200 tablets)

Why Was This Recalled?

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

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