Aurobindo Pharma Quinapril and Hydrochlorothiazide Tablets Recall

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lots QE2021005-A and QE2021010-A, exp 01/2023

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0021-2023
Classification: Class II
Status: Completed
Recall initiated: Oct 5, 2022
FDA report date: Nov 2, 2022
Quantity: 9504 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Aurobindo Pharma USA Inc.

Original FDA data

Every field from FDA enforcement report D-0021-2023, exactly as published.

Show all FDA fields

City: East Windsor
State: NJ
Status: Completed
Country: United States
Event ID: 90949
Address: 279 Princeton Hightstown Rd
Code information: Lots QE2021005-A and QE2021010-A, exp 01/2023
Postal code: 08520-1401
Report date: Nov 2, 2022
Product type: Drugs
Recall number: D-0021-2023
Classification: Class II
Recalling firm: Aurobindo Pharma USA Inc.
Product quantity: 9504 bottles
Reason for recall: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide
Recall initiation date: Oct 5, 2022
Initial firm notification: Letter
Center classification date: Oct 26, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0021-2023, published Nov 2, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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