Why it was recalled
Subpotent product:out of specification assay results observed during long term stability testing.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot#: A250043, EXP Date 06/30/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0238-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Nov 26, 2025
- FDA report date
- Dec 24, 2025
- Quantity
- 71,310 10mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SOMERSET THERAPEUTICS LLC
Original FDA data
Every field from FDA enforcement report D-0238-2026, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98063
- Address
- 300 Franklin Square Dr
- Code information
- Lot#: A250043, EXP Date 06/30/2026
- Postal code
- 08873-4187
- Report date
- Dec 24, 2025
- Product type
- Drugs
- Recall number
- D-0238-2026
- Classification
- Class III
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Product quantity
- 71,310 10mL vials
- Reason for recall
- Subpotent product:out of specification assay results observed during long term stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 26, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 15, 2025