# FDA recall D-0537-2026

> **Amerisource Health Services LLC** · Class III · drug recall initiated 2026-05-01.

## Product

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217.   Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

## Reason for recall

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0537-2026
- **Recalling firm:** Amerisource Health Services LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-05-01
- **Report date:** 2026-05-27

- **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-0537-2026

## Citation

> MORVS. FDA recall D-0537-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/D-0537-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*