Ramipril Capsules USP 5 mg — Class II drug recall D-0053-2025
Terminated recall by Lupin Pharmaceuticals Inc., reported 2024-11-27, distributed nationwide. CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
| Recall number | D-0053-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2024-10-23 |
| Classified | 2024-11-19 |
| Reported by FDA | 2024-11-27 |
| Terminated | 2026-01-05 |
| Distributed | Nationwide (US) |
| Quantity | 146,322 bottles |
| Reason classes | cgmp, unapproved product |
| NDC | 68180-0588, 68180-0588-01, 68180-0588-02, 68180-0588-09, 68180-0589, 68180-0589-01, 68180-0589-02, 68180-0589-09, 68180-0589-10, 68180-0590, 68180-0590-01, 68180-0590-02, 68180-0590-09, 68180-0590-10, 68180-0591, 68180-0591-01, 68180-0591-02, 68180-0591-09, 68180-0591-10 |
| Lot numbers | G326897, G326928, G326929, GA00854, GA00933, GA00954, GA00955, GA00964 |
| Expiration dates | 2025-09-30, 2025-12-31 |
Product
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Reason for recall
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
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-0053-2025. 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.