Recall: D-0368-2025

Class II - Potentially Harmful

Class IIClassification

2025-04-02Initiated

OngoingStatus

Amerisource Health Services LLFirm

Product

Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 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 68001-581-41.

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.