FDA Drugs recall ·
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL)… recall
- Recall number
- D-0236-2026
- Date
- (initiated November 26, 2025)
- Company / brand
- Somerset Therapeutics LLC
300 Franklin Square Dr, Somerset, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 52,340 5mL vials
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Subpotent product:out of specification assay results observed during long term stability testing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Distribution
Nationwide in the USA
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0236-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.