Indomethacin Extended-Release Capsules — Class II drug recall D-0454-2025
Ongoing recall by Amerisource Health Services LLC, reported 2025-06-11, distributed nationwide. cGMP deviations
| Recall number | D-0454-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2025-05-15 |
| Classified | 2025-06-02 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 21 cartons |
| Reason classes | cgmp |
| NDC | 68084-0411, 68084-0411-11, 68084-0411-21 |
| Lot numbers | 1021950 |
| Expiration dates | 2026-11-30 |
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 for recall
cGMP deviations
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-0454-2025. 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.