FDA Drugs recall ·
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL… recall
- Recall number
- D-0234-2026
- Date
- (initiated October 31, 2025)
- Company / brand
- Novocol Pharmaceutical of Canada, Inc.
25 Wolseley Crt, Cambridge, Canada - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,636 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Defective container: cracked/broken cartridges
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: D05004E, expires: 04-30-2027
Distribution
U.S.A. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0234-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.