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Recalls & Safety AlertsVersion 6

Fresenius Kabi Recalls 181,225 Vials of Lidocaine Injection After Hair Found in Products

An FDA enforcement report classifies the nationwide Class II recall of a single lot of 2% lidocaine injection as ongoing.

By AI ReporterUpdated Aug 7, 2026, 9:35 a.m. ET
has recalled of Lidocaine HCl Injection, USP, 2% because of the presence of particulate matter, according to an FDA enforcement report filed under recall number . The report gives the reason as "." The record lists the recall as initiated on 16 July 2026, with a report date of 29 July 2026, and distribution nationwide within the USA. The action is listed as , and this account reflects the agency record as it currently stands. The FDA record identifies the affected product as Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), supplied as 25 single-dose vials of 5 mL each, Rx only, sterile, from Fresenius Kabi, Lake Zurich, IL 60047, under NDC 63323-208-05 for the tray and 63323-208-01 for the vial. The identifying codes given are Lot #6133801, with an expiration date of 01/2028. According to the product's DailyMed labelling, this is a sterile, clear, colorless solution of lidocaine hydrochloride in water, with each millilitre containing 20 mg of lidocaine hydrochloride and 6 mg of sodium chloride; the vials are single-use and preservative-free, and the labelled route on this presentation is intravenous. The labelling describes a finished prescription pharmaceutical marked "Rx only," packaged in trays of 25 glass vials for professional use — the format bought by hospitals, clinics and pharmacies through drug distributors rather than handled directly by consumers. That labelling information describes the product generally and says nothing about this recall. The agency classified the recall as . By the FDA's own definition, is the middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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Sources

Revision history

  1. Version 67 Aug 2026, 13:35current

    No new facts; text unchanged and source list completed with the FDA enforcement record, Class II definition and DailyMed labelling URLs.

  2. Version 57 Aug 2026, 10:45

    Added a paragraph describing what the product is and how it is packaged and supplied, sourced to DailyMed labelling.

  3. Version 47 Aug 2026, 06:13

    Removed the product-composition paragraph, which was not supported by the current fact set, and added direct links to the FDA enforcement record and recall-classification definitions.

  4. Version 37 Aug 2026, 01:15

    Corrected the pH to the labelled range of about 5.0-7.0 and removed a molecular weight figure not present in the source record; added source links.

  5. Version 26 Aug 2026, 20:47

    Added headline and dek, corrected the product description to match the DailyMed labelling wording (removing the uncited sodium chloride figure), and added the source URLs.

  6. Version 16 Aug 2026, 16:17

    First published.

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