Fresenius Kabi Lidocaine HCl Injection Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Fresenius Kabi USA, LLC is recalling 181,225 vials of Lidocaine HCl Injection, USP, 2% due to the presence of particulate matter (hair).
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 Lidocaine HCl Injection, USP, 2% after hair was found in products, classified as Class II by the FDA.
Which Products Are Affected
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile. NDC Tray: 63323-208-05; NDC Vial: 63323-208-01. Lot #: 6133801, Exp. Date 01/2028. 181,225 vials distributed nationwide within the USA.
What You Should Do
Consumers and healthcare providers should follow guidance from the recalling firm or consult the FDA for further instructions regarding the affected product.
Why This Matters
The presence of particulate matter in injectable drugs may pose a risk of adverse reactions, prompting this nationwide recall of over 181,000 vials.
Source
FDA recall number D-0726-2026; Fresenius Kabi USA, LLC, Lake Zurich, IL.
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 (898 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.