FDA recall D-0236-2026

Product

Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.

Reason for recall

Subpotent product:out of specification assay results observed during long term stability testing.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-11-26

Report date

2025-12-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0236-2026