FDA-Drug2025-12-24Class IIPACKAGING DEFECT
Novocol Polocaine 3% dental anesthetic recalled for cracked cartridges
What this means
Novocol Polocaine 3% dental anesthetic cartridges in one specific lot may have cracked or broken containers. This defect could compromise the sterility and safety of the medication. No injuries have been reported.
- If you received Polocaine Lot D05159C (expires 07-31-2027), do not use it.
- Contact your supplier or Dentsply Pharmaceutical to report the affected cartridges.
- Check your inventory for Lot D05159C and set it aside.
The agency's original wording
Hazard
Defective container: cracked/broken cartridges
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.A. Nationwide
Affected count
5,825
Manufactured in
25 Wolseley Crt, Cambridge, Canada
Products
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.