Haloperidol decanoate Injection 50mg/mL — Class II drug recall D-0506-2024
Ongoing recall by SOMERSET THERAPEUTICS LLC, reported 2024-05-29, distributed nationwide. Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
| Recall number | D-0506-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SOMERSET THERAPEUTICS LLC, Somerset, NJ, United States |
| Recall initiated | 2024-04-24 |
| Classified | 2024-05-21 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 5,578 units |
| NDC | 70069-0030, 70069-0030-03, 70069-0030-05, 70069-0031, 70069-0031-01, 70069-0031-05, 70069-0381, 70069-0381-01, 70069-0381-10, 70069-0382, 70069-0382-01, 70069-0382-05, 70069-0383, 70069-0383-01, 70069-0383-05, 70069-0383-10, 70069-0384, 70069-0384-01, 70069-0384-05 |
| Expiration dates | 2025-07 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0506-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.