Somerset Therapeutics Private Limited recalls Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, So
Recalled April 16, 2025 · FDA recall D-0355-2025 · Somerset Therapeutics Private
Hazard
Lack of Assurance of Sterility: Media fill with bacterial contamination · FDA Class II
Units
997 vials
Sold at
U.S. Nationwide
Description
Lack of Assurance of Sterility: Media fill with bacterial contamination
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)
Manufacturer(s)
Somerset Therapeutics Private Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →