Drug FDA Class II Ongoing Quality

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.

Novocol Pharmaceutical of Canada, Inc. Published Dec 24, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Novocol Pharmaceutical of Canada, Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Defective container: cracked/broken cartridges

Affected products (1)

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.

XYLOCAINE · 18,789 cartons- 50 cartridges /carton

NDC: 66312-176, 66312-181, 66312-181-16, 66312-176-16

Lot codes: D05337B

Code info: Lot: D05337B, expires: 06-30-2027

Affected areas

Nationwide

Timeline

Initiated

Oct 31, 2025
Published

Dec 24, 2025

Recall number: D-0228-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.