Home / Recalls / Novocol Pharmaceutical of Canada, Inc. / D-0228-2026

D-0228-2026 Class II Ongoing

Recalled by Novocol Pharmaceutical of Canada, Inc. — Cambridge

Recall Details

Product Type
Drugs
Report Date
December 24, 2025
Initiation Date
October 31, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,789 cartons- 50 cartridges /carton

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.

Reason for Recall

Defective container: cracked/broken cartridges

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot: D05337B, expires: 06-30-2027

Other recalls by Novocol Pharmaceutical of Canada, Inc.

  • D-0231-2026 Class II — darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepiv (October 31, 2025)
  • D-0234-2026 Class II — OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton (October 31, 2025)
  • D-0230-2026 Class II — 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Inj (October 31, 2025)
  • D-0233-2026 Class II — Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP) (October 31, 2025)
  • D-0232-2026 Class II — Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepi (October 31, 2025)
  • D-0229-2026 Class II — Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Inject (October 31, 2025)
  • D-0127-2021 Class III — Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), pack (November 20, 2020)
  • D-923-2013 Class II — Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Den (August 14, 2013)