Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a c...

FDA Recall #D-0233-2026 — Class II — October 31, 2025

Recall #D-0233-2026 Date: October 31, 2025 Classification: Class II Status: Ongoing

Product Description

Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.

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

Product Quantity

40 cartons

Distribution

U.S.A. Nationwide

Code Information

Lot: D05159I, expires: 07-31-2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated