Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injec...

FDA Recall #D-0232-2026 — Class II — October 31, 2025

Recall #D-0232-2026 Date: October 31, 2025 Classification: Class II Status: Ongoing

Product Description

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.

Reason for Recall

Defective container: cracked/broken cartridges

Recalling Firm

Novocol Pharmaceutical of Canada, Inc. — Cambridge

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

U.S.A. Nationwide

Code Information

Lot: D05159H, expires: 07-31-2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated