Novocol Pharmaceutical of Canada, Inc. recalls 2% Xylocaine DENTAL with Epinephrine 1:100
- Recalling company
- Novocol Pharmaceutical of Canada, Inc.
- 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
- Defective container: cracked/broken cartridges
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 31, 2025
- Reported
- Dec 24, 2025
- Distribution
- U.S.A. Nationwide
- Status
- Ongoing
- Quantity
- 18,789 cartons- 50 cartridges /carton
- Lot / codes
- Lot: D05337B, expires: 06-30-2027
- Company location
- Cambridge
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0228-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0228-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.