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.

Quinapril and Hydrochlorothiazide Tablets Recalled by Aurobindo Pharma USA Inc. Due to CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the...

Date: October 5, 2022
Company: Aurobindo Pharma USA Inc.
Status: Completed
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 Aurobindo Pharma USA Inc. directly.

Affected Products

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90

Quantity: 9504 bottles

Why Was This Recalled?

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Aurobindo Pharma USA Inc.

Aurobindo Pharma USA Inc. has 47 total recalls tracked by RecallDetector.

Related Recalls

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