Fresenius Kabi Recalls Cisatracurium Besylate Injection Due to Labeling Error
Fresenius Kabi USA recalls 94,560 vials of Cisatracurium Besylate Injection due to incorrect labeling regarding preservative content.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Fresenius Kabi USA is recalling a specific lot of Cisatracurium Besylate Injection because the outer carton incorrectly states the product is 'Preservative free.' In reality, the vial and carton labels correctly identify that 0.9% benzyl alcohol has been added as a preservative. This discrepancy affects 94,560 vials distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/43014-fresenius-kabi-recalls-cisatracurium-besylate-injection-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/43014-fresenius-kabi-recalls-cisatracurium-besylate-injection-due-to-labeling-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-0819-2016
Cite this page
“Fresenius Kabi Recalls Cisatracurium Besylate Injection Due to Labeling Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43014-fresenius-kabi-recalls-cisatracurium-besylate-injection-due-to-labeling-error. Based on FDA recall #D-0819-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0819-2016%22&limit=1).
Why it’s dangerous
The primary danger is a labeling error where the carton claims the product is preservative-free, while the actual contents contain 0.9% benzyl alcohol. This could lead to inappropriate use in patients who have contraindications or sensitivities to benzyl alcohol, as they might believe they are receiving a different formulation.
Who’s affected
Healthcare providers and patients who received the specific lot of Cisatracurium Besylate Injection distributed between April 2016 and January 2017. Patients are at risk if they or their providers assume the drug lacks preservatives when it actually contains benzyl alcohol.
How to tell if you have this one
Check for Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), in 10 mL Multiple Dose Vials. Look for NDC 63323-417-10 and Lot # 6010157 with an expiration date of 01/2017. The packaging may incorrectly state 'Preservative free' on the individual carton label.
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Verify Product Details
Check your inventory for NDC 63323-417-10, Lot # 6010157, expiring in 01/2017.
Contact Manufacturer
Reach out to Fresenius Kabi USA for further instructions on handling the recalled vials.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0819-2016 (April 5, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0819-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.