Haloperidol Decanoate Injection 50mg/mL recalled over sterility concerns

Recall date

March 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Somerset Therapeutics Private Limited recalls Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, S…

Recall number

D-0355-2025

FDA classification

Class II

Brand / firm

Somerset Therapeutics Private Limited

Sold / distributed

U.S. Nationwide

Why it was recalled

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)