FDAClass IIIDecember 24, 2025

Cisatracurium Besylate Injection USP recall: Subpotent

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics…

Why was Cisatracurium Besylate Injection USP recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: A250020, Exp Date 06/30/2026

Product
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics…
Recalling firm
SOMERSET THERAPEUTICS LLC
Quantity
28,660 20mL vials
Distribution
Nationwide in the USA
Recall date
December 24, 2025
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls