Novocol Pharmaceutical of Canada, Inc. recalls OraVerse
- Recalling company
- Novocol Pharmaceutical of Canada, Inc.
- 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
- Reason
- Defective container: cracked/broken cartridges
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 31, 2025
- Reported
- Dec 24, 2025
- Distribution
- U.S.A. Nationwide
- Status
- Ongoing
- Quantity
- 1,636 cartons
- Lot / codes
- Lot: D05004E, expires: 04-30-2027
- Company location
- Cambridge
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0234-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0234-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.