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 Legacy Pharmaceutical Packaging LLC Due to CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric...

Date: April 24, 2019
Company: Legacy Pharmaceutical Packaging LLC
Status: Ongoing
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 Legacy Pharmaceutical Packaging LLC directly.

Affected Products

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

Quantity: 60,012 bottles

Why Was This Recalled?

CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

Where Was This Sold?

This product was distributed to 2 states: AZ, TN

Affected (2 states)Not affected

About Legacy Pharmaceutical Packaging LLC

Legacy Pharmaceutical Packaging LLC has 10 total recalls tracked by RecallDetector.

Related Recalls

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