D-0228-2026 Class II Ongoing
FDA drug recall D-0228-2026 was initiated by Novocol Pharmaceutical Of Canada, Inc. on Oct 31, 2025 and is designated Class II. Reason for recall: Defective container: cracked/broken cartridges The recall status is ongoing. Affected quantity: 18,789 cartons- 50 cartridges /carton.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 24, 2025
- Initiation Date
- Oct 31, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,789 cartons- 50 cartridges /carton
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.
Reason for recall
Defective container: cracked/broken cartridges
Distribution pattern
U.S.A. Nationwide
Code information
Lot: D05337B, expires: 06-30-2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0228-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026