ORAVERSE
Recalling Firm / Manufacturer: Novocol Pharmaceutical of Canada, Inc.
(Cambridge, Canada)
FDA Recall Number: D-0234-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
ORAVERSE
Generic Name
PHENTOLAMINE MESYLATE
Active Substance(s)
Phentolamine Mesylate
Administration Route
Submucosal
National Drug Code (NDC)
0362-0101
Total Quantity Recalled
1,636 cartons
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Defective container: cracked/broken cartridges
Full Product Description
Packaging specifications and labeling details
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
December 24, 2025
Firm Initiation Date
October 31, 2025
FDA Classification Date
Dec 12, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot: D05004E, expires: 04-30-2027
Distribution Information
Geographic scope of affected shipments
U.S.A. Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0234-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508608UTCC