Class IIReported 2025-12-24

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.

Recalled by Novocol Pharmaceutical of Canada, Inc.

Reason for Recall

Defective container: cracked/broken cartridges

Recall Number

D-0230-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-10-31

Reported

2025-12-24

Distribution

U.S.A. Nationwide

Code Info

Lot: D05159C, expires: 07-31-2027

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.