Novocol Pharmaceutical of Canada, Inc.: Drug Recall
Recall #D-0228-2026 · 10/31/2025
Class II: Risk
Recall Details
- Recall Number
- D-0228-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Novocol Pharmaceutical of Canada, Inc.
- Status
- Ongoing
- Date Initiated
- 10/31/2025
- Location
- Cambridge, Canada
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,789 cartons- 50 cartridges /carton
Reason for Recall
Defective container: cracked/broken cartridges
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.
Distribution Pattern
U.S.A. Nationwide
Other Recalls by Novocol Pharmaceutical of Canada, Inc.
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
View all recalls by Novocol Pharmaceutical of Canada, Inc. →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.