FDA Drug recall D-0355-2025
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, N…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, N… by Somerset Therapeutics Private, citing lack of Assurance of Sterility: Media fill with bacterial contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0355-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-21 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Somerset Therapeutics Private |
| Distribution | US |
Product
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Reason
Lack of Assurance of Sterility: Media fill with bacterial contamination
Identifiers
| ndc | 70069-030-05 |
|---|---|
| ndc | 70069-030-03 |
| ndc | 70069-031-01 |
| ndc | 70069-031-05 |
| ndc | 70069-381-01 |
| ndc | 70069-381-10 |
| ndc | 70069-382-01 |
| ndc | 70069-382-05 |
| ndc | 70069-383-05 |
| ndc | 70069-383-10 |
| ndc | 70069-383-01 |
| ndc | 70069-384-01 |
| ndc | 70069-384-05 |
| code_info | NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0355-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.