Why it was recalled
cGMP deviations
Product description
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).
Lot numbers, UPCs & expiration codes
Lot #: 1021950, Exp. 11/30/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0454-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 15, 2025
- FDA report date
- Jun 11, 2025
- Quantity
- 21 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0454-2025, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 96898
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: 1021950, Exp. 11/30/2026
- Postal code
- 43217-1188
- Report date
- Jun 11, 2025
- Product type
- Drugs
- Recall number
- D-0454-2025
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 21 cartons
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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).
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 15, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 2, 2025