FDA recall D-0228-2026

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 66312-176-16.

Reason for recall

Defective container: cracked/broken cartridges

Distribution

U.S.A. Nationwide

Key facts

Status

Ongoing

Initiation date

2025-10-31

Report date

2025-12-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2026