# FDA recall D-0368-2025

> **Amerisource Health Services LLC** · Class II · drug recall initiated 2025-04-02.

## Product

Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial,  Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.

## Reason for recall

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0368-2025
- **Recalling firm:** Amerisource Health Services LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-02
- **Report date:** 2025-04-30

- **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-0368-2025

## Citation

> AI Analytics. FDA recall D-0368-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0368-2025. Source: US FDA. Licensed CC0.

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