Oraverse Injection, Solution
FDA Recall NDC 0362-0101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Oraverse (NDC 0362-0101). A significant event, classified as Class II, was initiated on Oct 31, 2025 by Septodont, Inc.. The reported reason for this action was: "Defective container: cracked/broken cartridges"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective container: cracked/broken cartridges
Oct 31, 2025
Dec 24, 2025
1,636 cartons
Recall Profile & Regulatory Data
Event ID
98080
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Novocol Pharmaceutical of Canada, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: D05004E, expires: 04-30-2027
Affected Packages Involved in this Recall
0362-0101-10Product
Class III Terminated
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Apr 13, 2018
May 16, 2018
8509 boxes
Recall Profile & Regulatory Data
Event ID
79976
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Septodont Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA, Italy and France
Termination Date
Dec 14, 2020
Product Description
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10
Batch or Lot Expiration Information
Lot# 's D01894E and D01894G
Affected Packages Involved in this Recall
0362-0101-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
