2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton conta
Summary
The FDA issued a Class II for 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine In by Novocol Pharmaceutical of Canada, Inc.. Reason: Defective container: cracked/broken cartridges.
Details
Source
Drug Recall
External ID
D-0228-2026
Action Date
2025-12-24
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot: D05337B, expires: 06-30-2027
Quantity Affected: 18,789 cartons- 50 cartridges /carton
Reason for Recall
Defective container: cracked/broken cartridges
Distribution
U.S.A. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-31
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 91 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Novocol Pharmaceutical of Canada, Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novocol Pharmaceutical of Canada, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novocol Pharmaceutical of Canada, Inc. have FDA actions?
Novocol Pharmaceutical of Canada, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0228-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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