Lower riskDrug recall · FDA · Published July 22, 2020
Fresenius Kabi Dexmedetomidine HCl Injection Recall: Trace Lidocaine Cross Contamination
Fresenius Kabi recalls specific dexmedetomidine injection lots due to trace lidocaine cross contamination. This may cause adverse reactions in patients receiving IV infusions.
“Fresenius Kabi Dexmedetomidine HCl Injection Recall: Trace Lidocaine Cross Contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36918-fresenius-kabi-dexmedetomidine-hcl-injection-recall-trace-lidocaine-cross-contamination. Based on FDA recall #D-1537-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1537-2020%22&limit=1).
The FDA announced on July 22, 2020, that Fresenius Kabi USA, LLC voluntarily recalled Dexmedetomidine HCl in 0.9% Sodium Chloride Injection due to potential cross-contamination with lidocaine. The recall affects 25,100 bottles distributed nationwide.
How to tell if you have it
Brand: Fresenius Kabi
Product: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle
NDC: 63323-671-05
Lot codes: 6121853 (Exp 05/2021) and 6122207 (Exp 06/2021)
Quantity: 25,100 bottles
The hazard
The product may contain trace amounts of lidocaine due to cross-contamination with other products. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Fresenius Kabi USA, LLC has 65 other recalls on record since September 27, 2012. Recent recalls include the August 10, 2026 Tyenne Injection Recall for glass particles and the August 4, 2026 Morphine Syringes recall for wrong labeling. Other recent recalls of similar products include the June 8, 2026 Asclemed Lidocaine HCl Injection Recall and the February 5, 2026 Fresenius Kabi Ketamine HCl and Thiamine HCl Injection Recalls.
How to tell if you have this one
Check for the product name 'Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL)'. Look for lot numbers 6121853 (expires 05/2021) or 6122207 (expires 06/2021).
Brand
Fresenius Kabi
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Identify the lot number on the bottle, which should be 6121853 or 6122207 for this recall.
Contact Healthcare Provider
Inform your healthcare provider if you have used the recalled product to discuss potential risks and next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S.A. 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 2.1 years 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-1537-2020 (July 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1537-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.