Class IIReported 2025-04-30

Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.

Reason for Recall

Lack of assurance of sterility

Bacterial contamination detected in some media fill units

Recall Number

D-0369-2025

Classification

Class II

Status

Ongoing