Class IIReported 2025-04-16

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

Recall Number

D-0358-2025

Classification

Class II

Status

Ongoing