Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL)
Recalled by SOMERSET THERAPEUTICS LLC
Class III — least serious
Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
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.
Who this recall affects
This recall matters to anyone who bought Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL). Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: Nationwide in the USA.
What potency or effectiveness issue actually means
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.
In this case, the concern applies specifically to Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL) from SOMERSET THERAPEUTICS LLC — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lot#: A250043, EXP Date 06/30/2026
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- December 24, 2025
- Recall started
- November 26, 2025
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL) recalled?+
According to the FDA: Subpotent product:out of specification assay results observed during long term stability testing.
How serious is this recall?+
Class III — least serious. Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
What should I do if I have Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL)?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0238-2026. Information last synced from the FDA on August 17, 2026.