2% Xylocaine DENTAL with Epinephrine 1:100 recall
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
Why was 2% Xylocaine DENTAL with Epinephrine 1:100 recalled?
Defective container: cracked/broken cartridges
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: D05337B, expires: 06-30-2027
- Product
- 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
- Quantity
- 18,789 cartons- 50 cartridges /carton
- Distribution
- U.S.A. Nationwide
- Recall date
- December 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)