Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL)

SOMERSET THERAPEUTICS LLC has recalled Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 24, 2025 and was initiated on November 26, 2025. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), with approximately 71,310 10mL vials affected. The company behind the recall is SOMERSET THERAPEUTICS LLC, based in Somerset, NJ. The FDA describes the product as: “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-dos…”

Why was Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL) recalled?

According to the FDA, the stated reason for the recall is: “Subpotent product:out of specification assay results observed during long term stability testing.” In plain terms, this recall relates to a potency or effectiveness issue.

This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.

What should you do?

If you think you may have bought Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), compare it against the product description and identifying codes (Lot#: A250043, EXP Date 06/30/2026) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact SOMERSET THERAPEUTICS LLC or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.