Recalls / Class II
Class IID-0454-2025
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).
- Brand name
- Indomethacin
- Generic name
- Indomethacin
- Active ingredient
- Indomethacin
- Route
- Oral
- NDC
- 68084-411
- FDA application
- ANDA079175
- Affected lot / code info
- Lot #: 1021950, Exp. 11/30/2026
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 21 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-05-15
- FDA classified
- 2025-06-02
- Posted by FDA
- 2025-06-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0454-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.