Amerisource Health Services recalls Indomethacin capsules due to manufacturing deviations
Amerisource Health Services is recalling Indomethacin Extended-Release Capsules (75mg) due to cGMP deviations. This recall affects prescription-only products with specific lot numbers and expiration dates.
Recall notice
cGMP deviations
Contact the company
What happened, in plain English
Amerisource Health Services is recalling prescription Indomethacin Extended-Release Capsules (75mg) because of manufacturing deviations. This means the product may not be safe for use as intended. Read more at govinfonow.com/recall/32075-amerisource-health-services-recalls-indomethacin-capsules-due-to-manufacturing-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/32075-amerisource-health-services-recalls-indomethacin-capsules-due-to-manufacturing-deviations · Updated August 17, 2026 · FDA enforcement record: FDA #D-0454-2025
Cite this page
“Amerisource Health Services recalls Indomethacin capsules due to manufacturing deviations.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32075-amerisource-health-services-recalls-indomethacin-capsules-due-to-manufacturing-deviations. Based on FDA recall #D-0454-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0454-2025%22&limit=1).
Why it’s dangerous
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which means the product was made under conditions that do not meet safety and quality standards. This could potentially affect the drug's effectiveness or safety, but the exact risk is not specified in the recall notice.
Who’s affected
Prescription patients who have received this specific lot number of Indomethacin Extended-Release Capsules. Those with medical conditions requiring this medication are at higher risk.
How to tell if you have this one
Check for the lot number 1021950 on the carton. The product expires November 30, 2026. This recall applies to prescription-only Indomethacin Extended-Release Capsules with the specific NDC numbers.
- Brand
Amerisource Health Services- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number on the carton is 1021950 and the expiration date is November 30, 2026.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0454-2025 (May 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0454-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.