Class II U.S. Food and Drug Administration

Novocol Pharmaceutical of Canada, Inc. 2% Xylocaine Dental with Epinephrine 1:100,000 recall: Defective container: cracked/broken cartridges

Recall published 10 months ago

Defective container: cracked/broken cartridges

The hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

What the notice says: Defective container: cracked/broken cartridges

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0228-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Novocol Pharmaceutical of Canada, Inc.
Product type
Prescription & OTC drugs
Units affected
18,789 cartons- 50 cartridges /carton
Distribution
Nationwide
Made in
Canada
Lot / code info
Lot: D05337B, expires: 06-30-2027

Products covered by this recall

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.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • D05337B

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 06-30-2027 — 18
  • 789 cartons- 50 cartridge

NDC number

On the carton and again on the bottle or blister label.

  • 66312-176-16

Package size

Match the net weight or the piece count on the front of the pack.

  • 1.7 mL

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Novocol Pharmaceutical of Canada, Inc. — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Report side effects you think the product caused to FDA MedWatch.
  3. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  4. Ask the dispensing pharmacy for a replacement from an unaffected lot.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Novocol Pharmaceutical of Canada, Inc. — 25 Wolseley Crt, Cambridge

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Novocol Pharmaceutical of Canada, Inc. prescription & otc… recalled?

Defective container: cracked/broken cartridges Defective container: cracked/broken cartridges

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code D05337B; best-by date 06-30-2027 — 18 or 789 cartons- 50 cartridge. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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