FDA recall D-0355-2025

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 for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Distribution

U.S. Nationwide

Key facts

Status

Ongoing

Initiation date

2025-03-21

Report date

2025-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bengaluru, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0355-2025