Class IIReported 2025-04-30

Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.

Reason for Recall

Lack of assurance of sterility

Bacterial contamination detected in some media fill units

Recall Number

D-0367-2025

Classification

Class II

Status

Ongoing