FDAHealthOctober 31, 2025
Novocol Pharmaceutical of Canada, Inc. — 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
⚠️ Defective container: cracked/broken cartridges
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 31, 2025
U.S.A. Nationwide
What's affected?
- 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
- XYLOCAINE
- Lot code
- D05337B
Additional details
Lot: D05337B, expires: 06-30-2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 18,789 cartons- 50 cartridges /carton.
Get Health recall alerts
Delivered to your inbox. Free. No account required.