Class IIReported 2025-04-16

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Recall Number

D-0356-2025

Classification

Class II

Status

Ongoing