FDAFDA recall D-0729-2026 · Jul 29, 2026
Fresenius Kabi USA, LLC: Xylocaine (lidocaine HCl Injection recall
Recall found
Product
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
Reason for recall
Presence of Particulate Matter: Hair was found in products
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 6133986, Exp. Date 02/2029
- Quantity
- 37,250 vials
- Distribution
- Nationwide within in the USA
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-16
Source: openFDA enforcement record D-0729-2026 · search recall number D-0729-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.