Novocol Pharmaceutical of Canada, Inc.: Drug Recall

Recall #D-0231-2026 · 10/31/2025

Class II: Risk

Recall Details

Recall Number
D-0231-2026
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
5,520 Cartons

Reason for Recall

Defective container: cracked/broken cartridges

Product Description

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.

Distribution Pattern

U.S.A. Nationwide

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.