Recall: D-0367-2025

Class II - Potentially Harmful

Class IIClassification

2025-04-02Initiated

OngoingStatus

Amerisource Health Services LLFirm

Product

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

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.