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

Recall Summary Xylocaine DENTAL with Epinephrine (a local anesthetic used by dentists) is being recalled nationwide because some cartridges in affected batches are cracked or broken. The product is a prescription-only injection manufactured by Novocol Pharmaceutical of Canada for Dentsply Pharmaceutical, distributed across all U.S. states. This is classified as a Class I recall, the most serious type.

Recalling firm

Novocol Pharmaceutical of Canada, Inc.

Product

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.

Reason

Defective container: cracked/broken cartridges

Classification

Class I

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2025-10-31

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S.A. Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/807c48e5-18d8-4768-a4ed-f3d00182be6e