# FDA recall D-0257-2024

> **Amerisource Health Services LLC** · Class III · drug recall initiated 2023-12-26.

## Product

Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217.  Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11

## Reason for recall

Superpotent drug: Assay results were slightly above specification at the time zero point.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0257-2024
- **Recalling firm:** Amerisource Health Services LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-12-26
- **Report date:** 2024-01-31

- **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-0257-2024

## Citation

> AI Analytics. FDA recall D-0257-2024. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/D-0257-2024. Source: US FDA. Licensed CC0.

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