Class IIOngoing

Haloperidol Decanoate Injection 100mg/mL recall

FDA recall D-0357-2025 · initiated Mar 21, 2025

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

Why it was recalled

Lack of Assurance of Sterility: Media fill with bacterial contamination

Details

Product: Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
Recalling company: Somerset Therapeutics Private Limited
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide
Initiated: Mar 21, 2025
FDA report date: Apr 16, 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-0357-2025 ↗

← All drug recalls