OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, p… recall — Class II (D-0234-2026) · pharmaranks
Class IIOngoing
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing… recall
FDA recall D-0234-2026 · initiated Oct 31, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective container: cracked/broken cartridges
Details
Product
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
Recalling company
Novocol Pharmaceutical of Canada, Inc.
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
U.S.A. Nationwide
Initiated
Oct 31, 2025
FDA report date
Dec 24, 2025
This recall is linked to a product we cover: Oraverse →
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.