FDA-Drug2025-04-16Class II
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
Somerset Therapeutics Private Limited
Hazard
Lack of Assurance of Sterility: Media fill with bacterial contamination
Sold states
U.S. Nationwide
Affected count
4956 vials
Manufactured in
54/1 Budihal Village, N/A, Bengaluru, N/A, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0356-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief