Drug recall D-0228-2026

Class II Ongoing reported Dec 24, 2025

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.

Reason for recall

Defective container: cracked/broken cartridges

Lots and codes

Lot: D05337B, expires: 06-30-2027

Recall details

Recalling firm
Novocol Pharmaceutical of Canada, Inc., Cambridge
Quantity
18,789 cartons- 50 cartridges /carton
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
October 31, 2025

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