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Drug FDA Class II Ongoing Quality

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.

Novocol Pharmaceutical of Canada, Inc. Published Dec 24, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Novocol Pharmaceutical of Canada, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Defective container: cracked/broken cartridges

Affected products (1)

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.

CARBOCAINE · 40 cartons

NDC: 0362-0753, 0362-0753-05
Lot codes: D05159I
Code info: Lot: D05159I, expires: 07-31-2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 31, 2025
  2. Published
    Dec 24, 2025
Recall number
D-0233-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.