Class IIOngoing

Haloperidol Decanoate Injection recall

FDA recall D-0367-2025 · initiated Apr 2, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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.
Recalling company: Amerisource Health Services LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Apr 2, 2025
FDA report date: Apr 30, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0367-2025 ↗

← All drug recalls