Novocol Pharmaceutical of Canada, Inc.: Drug Recall

Recall #D-0230-2026 · 10/31/2025

Class II: Risk

Recall Details

Recall Number
D-0230-2026
Classification
Class II
Product Type
Drug
Recalling Firm
Novocol Pharmaceutical of Canada, Inc.
Status
Ongoing
Date Initiated
10/31/2025
Location
Cambridge, Canada
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,825

Reason for Recall

Defective container: cracked/broken cartridges

Product Description

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.

Distribution Pattern

U.S.A. Nationwide

Other Recalls by Novocol Pharmaceutical of Canada, Inc.

View all recalls by Novocol Pharmaceutical of Canada, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.