FDA recall D-0230-2026

Product

3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI 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 66312-441-16.

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-0230-2026