Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Losartan Potassium/HCTZ Recalled by RemedyRepack Inc. Due to CGMP Deviations: FDA lab confirmed presence of an...

Date: April 22, 2019
Company: RemedyRepack 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 RemedyRepack Inc. directly.

Affected Products

Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.

Quantity: 44 HDPE bottles of 90 = 3,960 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 of 0.96 parts per million.

Where Was This Sold?

Product was distributed to Florida.

About RemedyRepack Inc.

RemedyRepack Inc. has 60 total recalls tracked by RecallDetector.

Related Recalls

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