Agency classClass IIOur severity:High FDA (Drugs)·D-0728-2026·Announced 2026-07-29

Xylocaine Injection Recall Due to Hair Contamination

Fresenius Kabi is recalling 93,250 vials of Xylocaine (lidocaine HCl) injection due to the presence of particulate matter, specifically hair found in the product.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving particulate matter (hair) in an injectable drug product. While no illnesses or injuries have been reported, injectable products with foreign particle contamination pose a risk of harm if administered to patients.

Plain-English summary

Fresenius Kabi USA, LLC is recalling 93,250 vials of XYLOCAINE (lidocaine hydrochloride, epinephrine bitartrate) injection, 1%, 200 mg per 20 mL, in 25 multiple-dose vials. The product was distributed nationwide within the USA.

The recall is due to the presence of particulate matter, specifically hair found in the products. The affected lot number is 6130235 with an expiration date of 02/2027.

Healthcare providers and consumers who received the affected product should immediately check their inventory, quarantine any remaining units, and contact Fresenius Kabi to arrange for return or replacement. No illnesses or injuries have been reported in connection with this recall.

The recall was initiated as a precautionary measure after routine testing identified the presence of hair contamination in the injectable product.

The recalled product

Product: XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
Brand: XYLOCAINE
Manufacturer: Fresenius Kabi USA, LLC
Category: Drug — Injectable Anesthetic
Hazard: particulate-matter
foreign-contamination
Affected units: 93,250

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: 6130235
Exp. Date 02/2027

UPCs (14)

0363323484576
0363323485016
0363323483036
0363323487072
0363323486013
0363323495091
0363323488079
0363323489021
0363323495046
0363323491017
0363323492045
0363323492090
0363323482015
0363323481018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Fresenius Kabi USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same brand · XYLOCAINE

Moderate
FDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
High
Xylocaine Lidocaine Injectable Anesthetic Recalled for Storage Temperature Abuse
FDA (Drugs) · 2022-06-15
High
Xylocaine injectable anesthetic recalled for temperature abuse during manufacturing
FDA (Drugs) · 2022-06-15
Moderate
Xylocaine Lidocaine Injection Recalled for Low Epinephrine Assay Results
FDA (Drugs) · 2021-07-14

Same manufacturer · Fresenius Kabi USA, LLC

See all →

Severe
Fresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
Critical
Fresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
Moderate
Glycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
High
Lidocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
High
Naropin Injection Recall Over Particulate Matter Contamination
FDA (Drugs) · 2026-07-29

Same hazard · particulate matter