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Recalls & Safety AlertsVersion 6

Fresenius Kabi Recalls 92,600 Vials of Naropin Injection After Hair Found in Products

An FDA enforcement report dated July 29, 2026 lists the nationwide Class II recall of a single lot of the 0.5% ropivacaine hydrochloride injection as ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:12 a.m. ET
is recalling of Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), according to an FDA enforcement report carrying recall number . The reason given in the record is the presence of particulate matter: "Hair was found in products." The record lists the recall as initiated on July 16, 2026 and reported on July 29, 2026, with the status listed as . The FDA record identifies the affected product as Lot #6133436, expiration date 10/2028, packaged as twenty-five 20 mL single-dose vials, Rx only, from Fresenius Kabi, Lake Zurich, IL 60047, under NDC 63323-286-23 (tray) and 63323-286-05 (vial). Distribution is listed as nationwide within the USA. The agency classified the action as . By the FDA'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. The product is not a consumer purchase. According to the FDA-approved labeling published on DailyMed, ropivacaine hydrochloride injection is a sterile, clear, preservative-free solution of a manufactured amino amide compound, with sodium chloride added to make the solution isotonic and sodium hydroxide and/or hydrochloric acid used to adjust pH. Each milliliter contains 5 mg of the substance (0.5%), so a 20 mL single-dose vial holds 100 mg. It is given parenterally — by injection — by a trained clinician, and is supplied in sealed vials packaged into trays and distributed to hospitals, clinics and pharmacies. A member of the public cannot buy it off a shelf. The FDA 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, 14:12current

    Added headline and dek and attached the underlying FDA enforcement report, classification-definition and DailyMed labeling URLs to the story; text otherwise unchanged.

  2. Version 57 Aug 2026, 11:04

    Added source links for the FDA enforcement report, the Class II definition and the DailyMed labeling; trimmed unsourced product descriptors and standardized units spelling.

  3. Version 47 Aug 2026, 05:57

    Removed route-of-administration detail not supported by the fact set; added per-vial strength and prescription-status detail from the FDA-approved labeling, and added the supporting source URLs.

  4. Version 37 Aug 2026, 01:29

    Corrected product-description attribution to the FDA-approved labeling and DailyMed entries (removed unsourced NDC Directory reference and single-dose discard detail) and added the source URLs.

  5. Version 26 Aug 2026, 21:11

    Added source URLs and headline/dek; expanded product description with labeled routes and single-dose handling from DailyMed and the NDC Directory; removed the "developing matter" line.

  6. Version 16 Aug 2026, 16:37

    First published.

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