The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0228-2026·Announced 2025-12-24

Xylocaine dental cartridges recalled over cracked and broken containers

Novocol Pharmaceutical of Canada is recalling 18,789 cartons of 2% Xylocaine Dental with Epinephrine over a defective container with cracked or broken cartridges.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites cracked or broken cartridges with no stated clinical consequence or reported harm.

Plain-English summary

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCl and Epinephrine Injection USP), packaged in cartons containing 50 single-dose cartridges of 1.7 mL each, manufactured for Dentsply Pharmaceutical of York, Pennsylvania by Novocol Pharmaceutical of Canada, Inc., is being recalled.

The reason given in the enforcement record is a defective container: cracked or broken cartridges.

The recall covers 18,789 cartons at 50 cartridges per carton, from lot D05337B, expiry 06-30-2027. Distribution was nationwide in the USA. The FDA has classified the action as Class II.

The record describes a container defect and states no clinical consequence or reported injuries. Facilities should quarantine the affected lot and follow the firm's instructions.

The recalled product

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…
Manufacturer
Novocol Pharmaceutical of Canada, Inc.
Category
Drug — Dental injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: D05337B
  • expires: 06-30-2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Novocol Pharmaceutical of Canada, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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