# FDA recall D-0358-2025

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

## Product

Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

## Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0358-2025
- **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-0358-2025

## Citation

> AI Analytics. FDA recall D-0358-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0358-2025. Source: US FDA. Licensed CC0.

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