# FDA recall D-0506-2024

> **SOMERSET THERAPEUTICS LLC** · Class II · drug recall initiated 2024-04-24.

## Product

Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.

## Reason for recall

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0506-2024
- **Recalling firm:** SOMERSET THERAPEUTICS LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-04-24
- **Report date:** 2024-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerset, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0506-2024

## Citation

> AI Analytics. FDA recall D-0506-2024. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0506-2024. Source: US FDA. Licensed CC0.

---

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