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.
cGMP deviations
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.
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.
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.
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.
Verify the lot number on the carton is 1021950 and the expiration date is November 30, 2026.
The recall states there were cGMP deviations, but does not specify if the product is unsafe. The manufacturer has not provided details on the exact risk.
The recall record does not mention any replacement or remedy steps.
The recall record does not specify actions to take beyond checking the product details.
We’ve drafted a message you can send Amerisource Health Services to request your refund or repair — edit it as you like.
Subject: Recall D-0454-2025 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0454-2025 from Amerisource Health Services. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
