FDA Recall D-0238-2026

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

Quantity: 71,310 10mL vials

Reason for recall

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

Recall record

Recall number: D-0238-2026
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): 70069-161
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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