Cisatracurium Besylate Injection
FDA Recall NDC 70069-151
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Cisatracurium Besylate (NDC 70069-151). A significant event, classified as Class III, was initiated on Nov 26, 2025 by Somerset Therapeutics, Llc. The reported reason for this action was: "Subpotent product:out of specification assay results observed during long term stability testing."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Subpotent product:out of specification assay results observed during long term stability testing.
Nov 26, 2025
Dec 24, 2025
52,340 5mL vials
Recall Profile & Regulatory Data
Event ID
98063
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# : A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Affected Packages Involved in this Recall
70069-141-01Product
70069-141-10Product
70069-151-01Product
70069-151-10Product
Class III Ongoing
Subpotent product:out of specification assay results observed during long term stability testing.
Nov 26, 2025
Dec 24, 2025
28,660 20mL vials
Recall Profile & Regulatory Data
Event ID
98063
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
Batch or Lot Expiration Information
Lot# : A250020, Exp Date 06/30/2026
Affected Packages Involved in this Recall
70069-141-01Product
70069-141-10Product
70069-151-01Product
70069-151-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
