2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), pac...
FDA Recall #D-0228-2026 — Class II — October 31, 2025
Product Description
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.
Reason for Recall
Defective container: cracked/broken cartridges
Recalling Firm
Novocol Pharmaceutical of Canada, Inc. — Cambridge
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
18,789 cartons- 50 cartridges /carton
Distribution
U.S.A. Nationwide
Code Information
Lot: D05337B, expires: 06-30-2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated