Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Cisatracurium Besylate Injection USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent product:out of specification assay results observed during long term stability testing.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDCs
70069-0141-01
70069-0141-10
Compare with the code on your package — it is the most precise check available.
Drug: Cisatracurium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cisatracurium Besylate NDC 70069-0141 |
2 mg/mL | Injection Intravenous |
Somerset Therapeutics, LLC | Rx |
- Recalling firm
- Somerset Therapeutics LLC
- NDC code
- 70069-141-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0236-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Cisatracurium recalls
See all
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class I · High risk
Cisatracurium Besylate Injection
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Class II · Moderate risk
Cisatracurium Besylate Injection
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Class II · Moderate risk
Cisatracurium Besylate active pharmaceutical ingredient packaged…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Somerset Therapeutics LLC
All 2025 recalls
Class II · Moderate risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications
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