Xylocaine Lidocaine HCl Injection Recall for Particulate Matter
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Fresenius Kabi USA, LLC is recalling 37,250 vials of Xylocaine due to the presence of hair particulate matter.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
What Happened
Fresenius Kabi USA, LLC initiated a voluntary recall of Xylocaine (lidocaine HCl Injection, USP) due to the presence of particulate matter (hair) in the products.
Which Products Are Affected
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile. NDC Tray: 63323-485-57; NDC Vial: 63323-485-03. Lot #: 6133986, Exp. Date 02/2029. A total of 37,250 vials are affected. The recall is classified as Class II and was distributed nationwide within the USA.
What You Should Do
Consumers and healthcare providers should not use the affected product and should contact their healthcare provider or the recalling firm for further guidance.
Why This Matters
This Class II recall involves a drug product distributed nationwide that was found to contain particulate matter.
Source
FDA recall number D-0729-2026, report date 20260729.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (926 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.