FDA Drugs recall ·
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL)… recall
- Recall number
- D-0238-2026
- 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
- 71,310 10mL vials
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
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#: A250043, EXP Date 06/30/2026
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-0238-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.