The Recall Desk
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.

What this means for you

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 →

Related recalls

Same manufacturer · Novocol Pharmaceutical of Canada, Inc.

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Same hazard · defective container

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