Recall: D-0356-2025

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 by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41

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.