United StatesCisatracurium Besylate Injection USP in three presentations — 10 mg/5 mL (2 mg/mL) single‑dose vials (NDC 70069‑141‑01/10), 200 mg/20 mL (10 mg/mL) single‑dose vials (NDC 70069‑151‑01/10), and 20 mg/10 mL (2 mg/mL) multiple‑dose vials (NDC 70069‑161‑01/10) manufactured for Somerset Therapeutics and made in India are recalled; affected lots include A240438 (exp 1/31/2026), A250125 (exp 8/31/2026), A250020 (exp 6/30/2026) and A250043 (exp 6/30/2026). The recall was issued because long‑term stability testing showed out‑of‑specification (subpotent) assay results, and the products were distributed nationwide in the U.S.
What's being recalled
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.
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
Recalling firm: Somerset Therapeutics LLC, Somerset, NJ, United States.
How to identify it
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26 Lot #: A250020, Exp Date 06/30/2026 Lot#: A250043, EXP Date 06/30/2026
The hazard
Subpotent product:out of specification assay results observed during long term stability testing.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)