Quinapril and Hydrochlorothiazide Tablets — Class II drug recall D-0021-2023
Completed recall by Aurobindo Pharma USA Inc., reported 2022-11-02, distributed nationwide. CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
| Recall number | D-0021-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2022-10-05 |
| Classified | 2022-10-26 |
| Reported by FDA | 2022-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 9,504 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 65862-0161, 65862-0161-90, 65862-0162, 65862-0162-30, 65862-0162-90, 65862-0163, 65862-0163-90 |
| Lot numbers | QE2021005-A, QE2021010-A |
| Expiration dates | 2023-01 |
Product
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
Reason for recall
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0021-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.