FDAClass IIJune 11, 2025

Indomethacin Extended-Release Capsules recall: CGMP Deviations

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).

Why was Indomethacin Extended-Release Capsules recalled?

cGMP deviations

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 1021950, Exp. 11/30/2026

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).
Recalling firm
Amerisource Health Services LLC
Quantity
21 cartons
Distribution
Nationwide in the USA
Recall date
June 11, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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