FDA Recalls Xylocaine Injections Due to Hair Contamination
FDA is recalling Xylocaine (lidocaine HCl) injections due to the presence of particulate matter, specifically hair found in the product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves particulate contamination (hair) in an injectable drug, which poses a low-risk contamination concern rather than a high-risk pathogen or allergen issue.
Plain-English summary
Fresenius Kabi USA, LLC is recalling Xylocaine (lidocaine hydrochloride and epinephrine bitartrate) injection, 1%, 500 mg per 50 mL, packaged in 25 multiple-dose vials per tray. The recall affects lot number 6133986 with an expiration date of February 2029. A total of 37,250 vials are included in the recall, distributed nationwide within the USA.
The reason for the recall is the presence of particulate matter, specifically hair found in the product. This type of contamination raises concerns about sterility and product quality, as injectable medications must meet strict sterility standards.
Healthcare facilities and providers who received the affected product should immediately check their inventory, quarantine any remaining units from the recalled lot, and contact Fresenius Kabi USA, LLC to arrange for return or replacement. Patients currently receiving this medication should consult their healthcare provider to determine if an alternative treatment is needed.
No illnesses or injuries have been reported in connection with this recall. The recall is being conducted as a Class II recall, which means use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
- Brand
- XYLOCAINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Hazard
- particulate-contamination
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 #: 6133986
- Exp. Date 02/2029
UPCs (14)
- 0363323484576
- 0363323485016
- 0363323483036
- 0363323487072
- 0363323486013
- 0363323495091
- 0363323488079
- 0363323489021
- 0363323495046
- 0363323491017
- 0363323492045
- 0363323492090
- 0363323482015
- 0363323481018
Distribution
Distributed nationwide across the United States.
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