Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot: D05337B, expires: 06-30-2027
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0228-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 31, 2025
- FDA report date
- Dec 24, 2025
- Quantity
- 18,789 cartons- 50 cartridges /carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
Original FDA data
Every field from FDA enforcement report D-0228-2026, exactly as published.
Show all FDA fields
- City
- Cambridge
- Status
- Ongoing
- Country
- Canada
- Event ID
- 98080
- Address
- 25 Wolseley Crt
- Code information
- Lot: D05337B, expires: 06-30-2027
- Report date
- Dec 24, 2025
- Product type
- Drugs
- Recall number
- D-0228-2026
- Classification
- Class II
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
- Product quantity
- 18,789 cartons- 50 cartridges /carton
- Reason for recall
- Defective container: cracked/broken cartridges
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Oct 31, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 12, 2025