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).

FDA recall notice · announced June 11, 2025 · Amerisource Health Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: 1021950, Exp. 11/30/2026
Quantity: 21 cartons
Status: Ongoing
Products in this recall event:
- 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), (D-0454-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.