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Fresenius Kabi Recalls 59,425 Vials of Glycopyrrolate Injection After Hair Found in Product

An FDA enforcement report dated July 29, 2026 lists the nationwide Class II recall as ongoing.

By AI ReporterUpdated Aug 7, 2026, 9:25 a.m. ET
is recalling of Glycopyrrolate Injection, USP, after hair was found in the product, according to an [FDA enforcement report](https://api.fda.gov/food/enforcement.json?search=recall_number:%22D-0725-2026%22) carrying recall number . The report gives the reason as "." The firm initiated the recall 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 recalled product is described in the enforcement report as Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047, NDC Tray 63323-578-05 and NDC Vial 63323-578-07. The affected units are identified as Lot #6134349 and Lot #6134620, with an expiration date of 11/2026. The FDA classified the recall as . By [the agency's own definition](https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions), is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. Glycopyrrolate is a synthetic — laboratory-made, not plant- or animal-derived — quaternary ammonium salt, chemically 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide (C19H28BrNO3), according to DailyMed product labelling. In this presentation each millilitre is water for injection containing 0.2 mg of glycopyrrolate, with benzyl alcohol 0.9% as a preservative and the pH adjusted where needed with hydrochloric acid and/or sodium hydroxide. The labelling states it is given by intramuscular or intravenous injection, undiluted, rather than swallowed or applied externally, and that the presentation is a multiple-dose vial holding a 5 mL fill in a 6.5 mL vial, packed 25 vials to a tray. It is a finished, prescription-only medicine that moves through pharmaceutical distributors to hospitals, surgical centres and pharmacies, so the people who handle it are institutional buyers, pharmacists and clinicians rather than shoppers. This background describes the product generally and says nothing about the 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.

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Revision history

  1. Version 67 Aug 2026, 13:25current

    No new facts in the record; headline and dek added, story text unchanged.

  2. Version 57 Aug 2026, 11:51

    Added direct links to the FDA enforcement record and Class II definition, and trimmed product-background detail not supported by the cited labelling.

  3. Version 47 Aug 2026, 07:04

    Removed the uncited pH 2.0–3.0 range, added the labelled benzyl alcohol 0.9% preservative and molecular formula, and clarified the prescription-only distribution point per FDA definition.

  4. Version 37 Aug 2026, 02:12

    Removed unsourced formulation details (molecular formula, molecular weight, benzyl alcohol) and the PubChem attribution; product background now matches the supplied DailyMed reference data.

  5. Version 26 Aug 2026, 21:24

    Removed the uncited CDC multiple-dose-vial guidance and the unsourced preservative percentage, added the molecular weight and solubility from PubChem/DailyMed, and cited the FDA enforcement record and reference sources by URL.

  6. Version 16 Aug 2026, 17:15

    First published.

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