Recall: D-0355-2025

Class II - Potentially Harmful

Class IIClassification

2025-03-21Initiated

OngoingStatus

Somerset Therapeutics Private Firm

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)

Reason

Lack of Assurance of Sterility: Media fill with bacterial contamination

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.