FDA-Drug2025-12-24Class IIPACKAGING DEFECT
Novocol 2% Xylocaine Dental with Epinephrine recalled for cracked cartridges
What this means
Novocol Pharmaceutical issued a recall of 2% Xylocaine Dental with Epinephrine 1:100,000 injection cartridges due to defective containers—some cartridges are cracked or broken. This affects lot D05337B (expires 06-30-2027). The problem was discovered during quality control; no injuries have been reported.
- Check your dental office or clinic supply for lot D05337B cartridges
- Stop using any cracked or broken cartridges immediately
- Contact your supplier or Novocol Pharmaceutical for instructions on return or replacement
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
18,789 cartons- 50 cartridges /carton
Manufactured in
25 Wolseley Crt, Cambridge, Canada
Products
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine 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 66312-176-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2026Want us to check the next one for you?
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