Fresenius Kabi Xylocaine-MPF Recall: Low Epinephrine Assay Risk
Fresenius Kabi recalls Xylocaine-MPF with Epinephrine 1:200,000 injection due to low epinephrine assay results. This may affect medical use safety. Check vial NDC 63323-487-07 or tray NDC 63323-487-37 for affected units.
Lower-risk recall
Low out of specification results for epinephrine assay.
Contact the company
What happened, in plain English
Fresenius Kabi is recalling Xylocaine-MPF with Epinephrine 1:200,000 injections because the epinephrine content may be too low. This could lead to ineffective pain relief during medical procedures, though serious injury risks are not described in the recall. Read more at govinfonow.com/recall/36107-fresenius-kabi-xylocaine-mpf-recall-low-epinephrine-assay-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36107-fresenius-kabi-xylocaine-mpf-recall-low-epinephrine-assay-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0651-2021
Cite this page
“Fresenius Kabi Xylocaine-MPF Recall: Low Epinephrine Assay Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36107-fresenius-kabi-xylocaine-mpf-recall-low-epinephrine-assay-risk. Based on FDA recall #D-0651-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0651-2021%22&limit=1).
Why it’s dangerous
The epinephrine assay results are below the specified level, meaning the injection may not contain enough epinephrine to work effectively. This could result in inadequate pain control during medical procedures. However, the recall does not indicate a risk of serious injury or death.
Who’s affected
Healthcare providers using this injection for medical procedures. Patients receiving the injection under a doctor's supervision are most at risk if the epinephrine level is too low.
How to tell if you have this one
Check for vial NDC 63323-487-07 or tray NDC 63323-487-37. The product was sold with batch numbers 6123435, 6124730, 6124731 expiring January 2022 or July 2022.
- Brand
Fresen:ius Kabi- Category
Drug
What to do — step by step
Check Product Details
Identify the vial NDC 63323-487-07 or tray NDC 63323-487-37 to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 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-0651-2021 (June 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0651-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.