Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
OraVerse (Phentolamine Mesylate) Injection Recalled by Septodont Inc. Due to Failed Impurities/Degradation: This recall has been initiated due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Septodont Inc. directly.
Affected Products
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
Quantity: 8509 boxes
Why Was This Recalled?
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.
Where Was This Sold?
USA, Italy and France
About Septodont Inc.
Septodont Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report