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Class IIOngoing

Fresenius Kabi USA, LLC recalls 5 products

Recall date · record updated Jul 29, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Fresenius Kabi USA, LLC
Reason
Presence of Particulate Matter: Hair was found in product Presence of Particulate Matter: Hair was found in products
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Nationwide within in the USA
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99449…

Products (5)

  1. 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; NDC Vial: 63323-578-07

    Codes/lots: Lot #: 6134349, 6134620 Exp. Date 11/2026Quantity: 59,425 vialsRecall no. D-0725-2026Class II

  2. Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01

    Codes/lots: Lot #: 6133801, Exp. Date 01/2028Quantity: 181,225 vialsRecall no. D-0726-2026Class II

  3. Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

    Codes/lots: Lot #: 6133436, Exp. Date 10/2028Quantity: 92,600 vialsRecall no. D-0727-2026Class II

  4. Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

    Codes/lots: Lot #: 6130235, Exp. Date 02/2027Quantity: 93,250 vialsRecall no. D-0728-2026Class II

  5. Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

    Codes/lots: Lot #: 6133986, Exp. Date 02/2029Quantity: 37,250 vialsRecall no. D-0729-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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