Class II

Drug Recall: Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

Somerset Therapeutics Private Limited · March 21, 2025

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Distribution

U.S. Nationwide

States Affected

NATIONWIDE

Quantity Affected

240 vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0358-2025

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.

Somerset Therapeutics Private Limited Drug Recall: Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10 | SafeCheck