Dental anesthetic injection recalled for defective cartridge containers
Xylocaine (lidocaine with epinephrine) dental injection is being recalled due to defective containers with cracks or breaks. Defects could compromise product sterility and integrity.
What this means for you
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 injectable drug recall due to container defect (cracked/broken cartridges). No illnesses or injuries reported. Meets 'risk-of-harm product where injury has not yet been reported' criterion.
Plain-English summary
Xylocaine (lidocaine hydrochloride and epinephrine bitartrate) 2% dental injection in cartridges is being recalled. The product is manufactured by Novocol Pharmaceutical of Canada, Inc. for Dentsply Pharmaceutical and is used as a local anesthetic in dental procedures.
The recall was initiated because some cartridges in the affected lot contain cracks or breaks in the container. Defective containers could compromise the sterility and integrity of the medication.
The affected lot is D05337B (expiration date 06-30-2027), distributed nationwide in the U.S. The recall involves 18,789 cartons, each containing 50 single-dose cartridges of 1.7 mL. The product is identified by NDC 66312-176-16.
Healthcare providers and dental facilities should stop using cartridges from this lot immediately. Patients should contact their healthcare provider if they have concerns about the product.
The recalled product
- Product
- XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
- Brand
- XYLOCAINE
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Category
- Drug — Injectable / Dental
- Hazard
- cracked-cartridge
- container-defect
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: D05337B
- expires: 06-30-2027
Distribution
Distributed nationwide across the United States.
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