FDA Drug recall D-0454-2025
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health…
- FDA Drug
- Class II
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health… by Amerisource Health Services, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0454-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-15 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).
Reason
cGMP deviations
Identifiers
| ndc | 68084-411-11 |
|---|---|
| ndc | 68084-411-21 |
| code_info | Lot #: 1021950, Exp. 11/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0454-2025%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.