FDA Recall D-0454-2025
Amerisource Health Services LLC · Columbus, OH
Class II Ongoing 364 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0454-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2025-05-15
- Classified by FDA Center
- 2025-06-02
- FDA published
- 2025-06-11
- Recalling firm
- Amerisource Health Services LLC
- Firm location
- Columbus, OH
Drug identification
- Brand name(s)
- INDOMETHACIN
- Generic name(s)
- INDOMETHACIN
- Manufacturer(s)
- American Health Packaging
- NDC(s)
68084-411- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.