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 Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Recalled by Direct Rx Due to CGMP deviation: Trace amounts of impurity detected to...

Date: March 12, 2019
Company: Direct Rx
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 Direct Rx directly.

Affected Products

Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90

Quantity: 33 bottles

Why Was This Recalled?

CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.

Where Was This Sold?

This product was distributed to 1 state: FL

Affected (1 state)Not affected

About Direct Rx

Direct Rx has 36 total recalls tracked by RecallDetector.

Related Recalls

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