# FDA recall D-0454-2025

> **Amerisource Health Services LLC** · Class II · drug recall initiated 2025-05-15.

## 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).

## Reason for recall

cGMP deviations

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0454-2025
- **Recalling firm:** Amerisource Health Services LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-15
- **Report date:** 2025-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0454-2025

## Citation

> AI Analytics. FDA recall D-0454-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0454-2025. Source: US FDA. Licensed CC0.

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