FDA Recall D-0236-2026

SOMERSET THERAPEUTICS LLC · Somerset, NJ

Class III Ongoing 169 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26

Quantity: 52,340 5mL vials

Reason for recall

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

Recall record

Recall number: D-0236-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-11-26
Classified by FDA Center: 2025-12-15
FDA published: 2025-12-24
Recalling firm: SOMERSET THERAPEUTICS LLC
Firm location: Somerset, NJ

Drug identification

Brand name(s): CISATRACURIUM BESYLATE
Generic name(s): CISATRACURIUM BESYLATE
Manufacturer(s): Somerset Therapeutics, LLC
NDC(s): 70069-141, 70069-151
Route(s): INTRAVENOUS

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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