FDA Drugs recall ·
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and… recall
- Recall number
- D-0228-2026
- Date
- (initiated October 31, 2025)
- Company / brand
- Novocol Pharmaceutical of Canada, Inc.
25 Wolseley Crt, Cambridge, Canada - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18,789 cartons- 50 cartridges /carton
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Defective container: cracked/broken cartridges
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: D05337B, expires: 06-30-2027
Distribution
U.S.A. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0228-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.