Lower riskDrug recall · FDA · Published November 17, 2020
Fresenius Kabi Dexmedetomidine Injection Recall: Cross Contamination Risk
Fresenius Kabi recalls specific dexmedetomidine injection due to trace lidocaine contamination. Patients using this medication may face unintended effects from cross-contamination.
“Fresenius Kabi Dexmedetomidine Injection Recall: Cross Contamination Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36682-fresenius-kabi-dexmedetomidine-injection-recall-cross-contamination-risk. Based on FDA recall #D-0120-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0120-2021%22&limit=1).
Fresenius Kabi USA, LLC voluntarily recalled Dexmedetomidine HCl in 0.9% Sodium Chloride Injection due to cross-contamination with trace amounts of lidocaine, the FDA said on Nov. 17, 2020.
How to tell if you have it
Brand: Fresenius Kabi
Product: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle
NDC: 63323-671-05
Lot #: 6123925
Quantity: 13,525 bottles
The hazard
The recall involves cross-contamination with other products, specifically trace amounts of lidocaine in the Dexmedetomidine HCl injection.
Context
GovInfoNow's records show Fresenius Kabi USA, LLC has 65 other recalls on record since Sept. 27, 2012. Recent similar recalls include a Tyenne Injection recall for glass particles (Aug. 10, 2026), Morphine syringes with wrong labeling (Aug. 4, 2026), and Xylocaine Injection with hair found in products (July 16, 2026). Other recent recalls of similar products include an Asclemed Lidocaine HCl Injection recall for contaminated medication (June 8, 2026), a Fresenius Kabi acyclovir injection recall for lack of sterility assurance (Feb. 5, 2026), and a Fresenius Kabi Thiamine HCl Injection recall for lack of sterility assurance (Feb. 5, 2026).
How to tell if you have this one
Check for the product name 'Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle'. The lot number 6123925 is associated with this recall.
Brand
Fresenius Kabi
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name and lot number to confirm if it's part of this recall.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0120-2021 (November 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0120-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.