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Novocol Pharmaceutical of Canada, Inc. recalls 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton conta

Recalled December 24, 2025 · FDA recall D-0228-2026 · Novocol Pharmaceutical of Canada

Hazard
Defective container: cracked/broken cartridges · FDA Class II
Units
18,789 cartons- 50 cartridges /carton
Sold at
U.S.A. Nationwide

Description

Defective container: cracked/broken cartridges

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.
Manufacturer(s)
Novocol Pharmaceutical of Canada, Inc.
Made in
Canada

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Novocol Pharmaceutical of Canada, Inc. recalls 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton conta | RecallWatchUSA