PlainRecalls
FDA Drug Moderate Class II Ongoing

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).

Reported: June 11, 2025 Initiated: May 15, 2025 #D-0454-2025

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).

Reason for Recall

cGMP deviations

Details

Units Affected
21 cartons
Distribution
Nationwide in the USA
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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).. Recalled by Amerisource Health Services LLC. Units affected: 21 cartons.
Why was this product recalled?
cGMP deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on June 11, 2025. Severity: Moderate. Recall number: D-0454-2025.