Home / Recalls / SOMERSET THERAPEUTICS LLC / D-0238-2026

D-0238-2026 Class III Ongoing

Recalled by SOMERSET THERAPEUTICS LLC — Somerset, NJ

Recall Details

Product Type
Drugs
Report Date
December 24, 2025
Initiation Date
November 26, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
71,310 10mL vials

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.

Reason for Recall

Subpotent product:out of specification assay results observed during long term stability testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot#: A250043, EXP Date 06/30/2026

Other recalls by SOMERSET THERAPEUTICS LLC

  • D-0237-2026 Class III — Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-do (November 26, 2025)
  • D-0236-2026 Class III — Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dos (November 26, 2025)
  • D-0169-2025 Class III — Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufacture (December 16, 2024)
  • D-0506-2024 Class II — Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials ( (April 24, 2024)
  • D-1375-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufacture (June 4, 2020)
  • D-1374-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufacture (June 4, 2020)
  • D-1373-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured (June 4, 2020)