Class IIOngoing

Haloperidol Decanoate Injection 50mg/mL recall

FDA recall D-0355-2025 · 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 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
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-0355-2025 ↗

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