FDA Drug recall D-0021-2023
Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hig…
- FDA Drug
- Class II
- completed
- Published 2022-11-02
On 2022-11-02 the FDA classified a Class II recall of Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hig… by Aurobindo Pharma Usa, citing CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0021-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-10-05 |
| Published | 2022-11-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
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
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Identifiers
| ndc | 65862-161-90 |
|---|---|
| ndc | 65862-162-30 |
| ndc | 65862-162-90 |
| ndc | 65862-163-90 |
| code_info | Lots QE2021005-A and QE2021010-A, exp 01/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Other recalls by Aurobindo Pharma Usa
- Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown…
FDA Drug · Class II · 2026-08-12 · Aurobindo Pharma Usa - Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 7228…
FDA Drug · Class II · 2025-06-25 · Aurobindo Pharma Usa - Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Wind…
FDA Drug · Class II · 2024-12-25 · Aurobindo Pharma Usa - Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, D…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa - Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Di…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa
All Aurobindo Pharma Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0021-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.