Recalls / Class II
Class IID-0228-2026
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.
- Brand name
- Xylocaine
- Generic name
- Lidocaine Hydrochloride And Epinephrine Bitartrate
- Active ingredients
- Epinephrine Bitartrate, Lidocaine Hydrochloride
- Route
- Submucosal
- NDCs
- 66312-176, 66312-181
- FDA application
- ANDA088390
- Affected lot / code info
- Lot: D05337B, expires: 06-30-2027
Why it was recalled
Defective container: cracked/broken cartridges
Recalling firm
- Firm
- Novocol Pharmaceutical of Canada, Inc.
- Manufacturer
- Dentsply Pharmaceutical
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Wolseley Crt, Cambridge, N/A, Canada
Distribution
- Quantity
- 18,789 cartons- 50 cartridges /carton
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2025-10-31
- FDA classified
- 2025-12-12
- Posted by FDA
- 2025-12-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0228-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.