Recall: D-0454-2025

Class II - Potentially Harmful

Class IIClassification

2025-05-15Initiated

OngoingStatus

Amerisource Health Services LLFirm

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.