Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Indomethacin Extended-Release Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What 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).
Affected NDCs
68084-0411-11
68084-0411-21
Compare with the code on your package — it is the most precise check available.
Drug: Indomethacin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Indomethacin NDC 68084-0411 |
75 mg/1 | Capsule, Extended Release Oral |
American Health Packaging | Rx |
- Recalling firm
- Amerisource Health Services LLC
- NDC code
- 68084-411-21
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0454-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Indomethacin recalls
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Class II · Moderate risk
Indomethacin Extended-Release Capsules
CGMP Deviations
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