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 and Hydrochlorothiazide Tablets Recalled by AVKARE Inc. Due to CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid...

Date: March 5, 2019
Company: AVKARE 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 AVKARE Inc. directly.

Affected Products

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15

Quantity: N/A

Why Was This Recalled?

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AVKARE Inc.

AVKARE Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

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