Recall archive / FDA drug enforcement

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Steri... — FDA record D-0726-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 16, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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
Reason: Presence of Particulate Matter: Hair was found in products
Classification: Class II
Recalling firm: Fresenius Kabi USA, LLC
Quantity: 181,225 vials
Agency-reported status: Ongoing
Source record identifier: D-0726-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot #: 6133801, Exp. Date 01/2028

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 29, 2026
Recall initiation date: Jul 16, 2026
Center classification date: Jul 23, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.