FDA Drug recall D-0054-2025
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, R…
- FDA Drug
- Class II
- terminated
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, R… by Lupin Pharmaceuticals, citing CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0054-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-10-23 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Reason
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Identifiers
| ndc | 68180-589-09 |
|---|---|
| ndc | 68180-589-10 |
| ndc | 68180-589-01 |
| ndc | 68180-589-02 |
| ndc | 68180-590-09 |
| ndc | 68180-590-10 |
| ndc | 68180-590-01 |
| ndc | 68180-590-02 |
| ndc | 68180-591-09 |
| ndc | 68180-591-10 |
| ndc | 68180-591-02 |
| ndc | 68180-591-01 |
| ndc | 68180-588-01 |
| ndc | 68180-588-02 |
| ndc | 68180-588-09 |
| code_info | a) NDC 68180-591-09; Lots G327086, exp. date 30-Sep-25 GA01065, exp. date 31-Dec-25, b) NDC 68180-591-01 Lots G3250…a) NDC 68180-591-09; Lots G327086, exp. date 30-Sep-25 GA01065, exp. date 31-Dec-25, b) NDC 68180-591-01 Lots G325033, G324987, exp. date 31-Jul-25, G325110, GA00956, GA01066, GA01126, exp. date 31-Dec-25, GA03299, GA03288, GA03287, exp. date 31-Mar-26 c) NDC 68180-591-02 Lot GA05919, exp. date 31-Jul-26 G327131, exp. date 30-Sep-25 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0054-2025%22
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