Indomethacin Extended-Release Capsules recall
FDA recall D-0454-2025 · initiated May 15, 2025
Amerisource Health Services LLC recalled Indomethacin Extended-Release Capsules in May 2025 — an FDA Class II recall (D-0454-2025) because cGMP deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 21 cartons
Details
- 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 company
- Amerisource Health Services LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 15, 2025
- FDA report date
- Jun 11, 2025
Frequently asked
- Was Indomethacin Extended-Release Capsules recalled?
- Amerisource Health Services LLC recalled Indomethacin Extended-Release Capsules in May 2025 — an FDA Class II recall (D-0454-2025) because cGMP deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Indomethacin Extended-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0454-2025 was: cGMP deviations
- Is a recalled Indomethacin Extended-Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Indomethacin Extended-Release Capsules are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: 1021950, Exp. 11/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0454-2025.