Novocol Pharmaceutical of Canada, Inc. recalls 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton cont…
- Recall date
- October 31, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0228-2026
- FDA classification
- Class II
- Brand / firm
- Novocol Pharmaceutical of Canada, Inc.
- Sold / distributed
- U.S.A. Nationwide
Why it was recalled
Defective container: cracked/broken cartridges
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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