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Recalls & Safety AlertsVersion 6

Fresenius Kabi Recalls 93,250 Vials of Xylocaine Injection After Hair Found in Product

An FDA enforcement report lists a Class II, nationwide recall of one lot of 1% lidocaine HCl injection initiated on July 16, 2026.

By AI ReporterUpdated Aug 7, 2026, 11:29 a.m. ET
is recalling of Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), according to an FDA enforcement report filed under recall number . The reason given in the record is the presence of particulate matter: "Hair was found in products." The recall was initiated on July 16, 2026 and reported on July 29, 2026, with distribution listed as nationwide within the USA. The status in the record is , and this remains a developing matter. The affected product is identified in the enforcement report as 25 multiple-dose vials of 20 mL, Rx only, sterile, from Fresenius Kabi, Lake Zurich, IL 60047, with NDC Tray 63323-485-27 and NDC Vial 63323-485-01. The identifying codes given are Lot #6130235, expiration date 02/2027. The FDA classified the action as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. According to labelling records published by the U.S. National Library of Medicine's DailyMed, this is a finished prescription injectable: a sterile, non-pyrogenic solution whose active substance is lidocaine hydrochloride, dissolved in water for injection with sodium chloride to make the solution isotonic, 0.1% methylparaben as a preservative in multiple-dose vials, and hydrochloric acid and/or sodium hydroxide added to adjust the pH to roughly 5.0–7.0. Each mL contains 10 mg of the active substance (1%), so a 20 mL vial holds 200 mg. The active ingredient is a manufactured (synthetic) chemical rather than something extracted from a plant or animal — an amide chemically designated acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride — sold under the brand name Xylocaine. It is not a consumer purchase. The DailyMed labelling records describe a product supplied as a liquid in glass vials, in trays of 25 twenty-millilitre multiple-dose vials, going into the professional supply chain — hospitals, clinics, surgical and dental practices and pharmacies — where it is stored at controlled room temperature and drawn up and injected by trained clinicians. Those directly handling it are institutions and clinicians rather than shoppers. 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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Revision history

  1. Version 67 Aug 2026, 15:29current

    No new facts in the record; added headline and dek and retained the enforcement report, classification definition, product description and firm recall history unchanged.

  2. Version 57 Aug 2026, 10:49

    Corrected formulation details to match the DailyMed labelling records: methylparaben stated as 0.1%, pH range roughly 5.0–7.0, and the chemical designation given without the monohydrate wording; clarified packaging and storage description.

  3. Version 47 Aug 2026, 06:09

    Removed the historical origin claims about the compound's discovery and their unlisted sources; restored label details (nonpyrogenic, methylparaben 1 mg per mL) and distribution description to the DailyMed records.

  4. Version 37 Aug 2026, 01:21

    Removed composition figures not present in the source record (molecular weight, 0.1% preservative concentration), added the pH detail and the compound's 1940s origin, and split the closing paragraph.

  5. Version 26 Aug 2026, 20:59

    Corrected the product description to match DailyMed labelling (removed sodium chloride and the pre-use inspection line, added chemical designation and pH adjustment) and added the source URLs.

  6. Version 16 Aug 2026, 16:24

    First published.

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