Somerset Therapeutics Private Limited recalls Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited,
Recalled April 16, 2025 · FDA recall D-0357-2025 · Somerset Therapeutics Private
Hazard
Lack of Assurance of Sterility: Media fill with bacterial contamination · FDA Class II
Units
23,960 vials
Sold at
U.S. Nationwide
Description
Lack of Assurance of Sterility: Media fill with bacterial contamination
Product
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
Manufacturer(s)
Somerset Therapeutics Private Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →