2% Xylocaine DENTAL with Epinephrine 1:100
Recalled by Novocol Pharmaceutical of Canada, Inc.
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Novocol Pharmaceutical of Canada, Inc. has recalled 2% Xylocaine DENTAL with Epinephrine 1:100, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 24, 2025 and was initiated on October 31, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers 2% Xylocaine DENTAL with Epinephrine 1:100, with approximately 18,789 cartons- 50 cartridges /carton affected. The company behind the recall is Novocol Pharmaceutical of Canada, Inc., based in Cambridge. The FDA describes the product as: “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…”
Why was 2% Xylocaine DENTAL with Epinephrine 1:100 recalled?
According to the FDA, the stated reason for the recall is: “Defective container: cracked/broken cartridges.”
What should you do?
If you think you may have bought 2% Xylocaine DENTAL with Epinephrine 1:100, compare it against the product description and identifying codes (Lot: D05337B, expires: 06-30-2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Novocol Pharmaceutical of Canada, Inc. or your local health authority.
About this recall
This recall was distributed in U.S.A. Nationwide. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- December 24, 2025
- Recall started
- October 31, 2025
- Distributed in
- U.S.A. Nationwide
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was 2% Xylocaine DENTAL with Epinephrine 1:100 recalled?+
According to the FDA: Defective container: cracked/broken cartridges
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have 2% Xylocaine DENTAL with Epinephrine 1:100?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0228-2026. Information last synced from the FDA on July 5, 2026.