FDA recall D-0233-2026

Product

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

Distribution

U.S.A. Nationwide

Key facts

Status

Ongoing

Initiation date

2025-10-31

Report date

2025-12-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0233-2026