Class II

Drug Recall: 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 (10x

Somerset Therapeutics Private Limited · March 21, 2025

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Product Description

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)

Distribution

U.S. Nationwide

States Affected

NATIONWIDE

Quantity Affected

997 vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0355-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.