# FDA recall D-0357-2025

> **Somerset Therapeutics Private Limited** · Class II · drug recall initiated 2025-03-21.

## Product

Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories  NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)

## Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0357-2025
- **Recalling firm:** Somerset Therapeutics Private Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-21
- **Report date:** 2025-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bengaluru, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0357-2025

## Citation

> AI Analytics. FDA recall D-0357-2025. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0357-2025. Source: US FDA. Licensed CC0.

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