WhichRecall
Class IIReported 2025-12-24

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.

Recalled by Novocol Pharmaceutical of Canada, Inc.

Reason for Recall

Defective container: cracked/broken cartridges

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Recall Number
D-0228-2026
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-10-31
Reported
2025-12-24
Distribution
U.S.A. Nationwide
Code Info
Lot: D05337B, expires: 06-30-2027
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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