Drug FDA Class II Ongoing cGMP deviation
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).
Amerisource Health Services LLC Published Jun 11, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Amerisource Health Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
cGMP deviations
Affected products (1)
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).
INDOMETHACIN · 21 cartons
NDC: 68084-411, 68084-411-11, 68084-411-21
Code info: Lot #: 1021950, Exp. 11/30/2026
Affected areas
Nationwide
Timeline
- InitiatedMay 15, 2025
- PublishedJun 11, 2025
- Recall number
- D-0454-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.