Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

2% Xylocaine DENTAL with Epinephrine 1:100 Recalled by Novocol Pharmaceutical of Canada, Inc. Due to Defective container: cracked/broken cartridges

Date: October 31, 2025
Company: Novocol Pharmaceutical of Canada, Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Novocol Pharmaceutical of Canada, Inc. directly.

Affected Products

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.

Quantity: 18,789 cartons- 50 cartridges /carton

Why Was This Recalled?

Defective container: cracked/broken cartridges

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Novocol Pharmaceutical of Canada, Inc.

Novocol Pharmaceutical of Canada, Inc. has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report