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 USP 100 mg Recalled by Avet Pharmaceuticals, Inc. Due to CGMP Deviations: FDA lab confirmed presence of an...

Date: March 26, 2020
Company: Avet Pharmaceuticals, 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 Avet Pharmaceuticals, Inc. directly.

Affected Products

Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816

Quantity: a) 12,168; b) 17,196; c) 3,890

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Avet Pharmaceuticals, Inc.

Avet Pharmaceuticals, Inc. has 4 total recalls tracked by RecallDetector.

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