Quinapril Tablets USP — Class II drug recall D-0089-2023
Terminated recall by Lupin Pharmaceuticals Inc., reported 2022-12-28, distributed nationwide. CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
| Recall number | D-0089-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2022-12-07 |
| Classified | 2022-12-23 |
| Reported by FDA | 2022-12-28 |
| Terminated | 2024-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 23,736 |
| Reason classes | cgmp, specification failure |
| NDC | 68180-0554, 68180-0554-03, 68180-0554-09, 68180-0556, 68180-0556-09, 68180-0557, 68180-0557-03, 68180-0557-09, 68180-0558, 68180-0558-03, 68180-0558-09, 68180-0559, 68180-0559-03, 68180-0559-09 |
| Lot numbers | G102929 |
| Expiration dates | 2023-04 |
Product
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
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-0089-2023. 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.