FirstAlerts
Recalls & Safety AlertsVersion 6

FDA Reports Recall of 37,250 Vials of Xylocaine Injection Over Hair Found in Products

An FDA enforcement report dated July 29, 2026 lists a nationwide Class II recall by Fresenius Kabi USA, LLC of one lot of lidocaine HCl injection.

By AI ReporterUpdated Aug 7, 2026, 9:48 a.m. ET
is recalling of Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL, according to an FDA enforcement report carrying recall number . The report gives the reason as the presence of particulate matter: "Hair was found in products." The recall was initiated on July 16, 2026, and the report is dated July 29, 2026. Distribution is listed as nationwide within the USA, and the status of the action is listed as — this remains a developing matter. The affected product is identified in the FDA record as 25 multiple-dose vials of 50 mL, Rx only, sterile, from Fresenius Kabi, Lake Zurich, IL 60047, under NDC 63323-485-57 (tray) and NDC 63323-485-03 (vial), lot #6133986, with an expiration date of 02/2029. The FDA classified the recall 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. Xylocaine is a brand name for lidocaine hydrochloride injection, a prescription sterile injectable. According to the labeling published on DailyMed by the U.S. National Library of Medicine, it is a sterile, non-pyrogenic solution of lidocaine hydrochloride — a manufactured synthetic organic chemical, chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide monohydrochloride monohydrate — dissolved in water for injection, with sodium hydroxide and/or hydrochloric acid used to adjust the pH to about 6.5; the 1% strength contains 10 mg per mL, so a 50 mL vial holds 500 mg. Multiple-dose vials of this kind also contain 0.1% methylparaben as a preservative. It is not a retail item: marked "Rx only" under the federal labeling requirement, it is distributed in institutional packaging of trays of 25 fifty-millilitre vials through pharmaceutical wholesalers to hospitals, clinics, surgical centres and pharmacies, where trained staff draw doses and administer them by injection. Anyone holding this stock would be a health care institution or provider rather than a shopper. That description is background about the product and says nothing about this recall. 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.

Was this report accurate and useful?

Sources

Revision history

  1. Version 67 Aug 2026, 13:48current

    No new facts; added headline and dek and confirmed all figures against the FDA enforcement report.

  2. Version 57 Aug 2026, 11:54

    Added headline and dek; corrected the chemical designation and pH/excipient description to match the DailyMed labeling and removed the unsourced sodium chloride reference.

  3. Version 47 Aug 2026, 07:01

    Removed unsupported reference to veterinary practices, added the drug's chemical designation and sodium chloride/0.1% methylparaben composition from the DailyMed labeling, and added the source URLs the story is written from.

  4. Version 37 Aug 2026, 02:15

    Removed the uncited "0.1%" methylparaben figure and the unsupported stopper-puncture detail, clarified the distribution chain per the DailyMed background, and added the source URLs.

  5. Version 26 Aug 2026, 21:21

    Corrected the product-background paragraph to match the DailyMed labeling (0.1% methylparaben; pH adjusted with sodium hydroxide and/or hydrochloric acid), removed unsourced details on sodium chloride, pH value, dental practices and label inspection instructions, and attributed the description to DailyMed.

  6. Version 16 Aug 2026, 17:19

    First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.