Septodont Inc. recalls OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx
Septodont recalls OraVerse (Phentolamine Mesylate) injections due to impurity detected at 15-month stability testing. Affected lots D01894E and D01894G may pose risks from degradation products.
Lower-risk recall
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.
Contact the company & request your remedy
What happened, in plain English
Septodont is recalling OraVerse injections that were found to have impurities at the 15-month stability test. This could mean the product might degrade over time, potentially causing harm if used. Read more at govinfonow.com/recall/40614-septodont-oraverse-injection-recall-impurity-risk-in-15-month-stability.
Source Summary by GovInfoNow · govinfonow.com/recall/40614-septodont-oraverse-injection-recall-impurity-risk-in-15-month-stability · Updated October 7, 2026 · FDA enforcement record: FDA #D-0828-2018
Cite this page
“Septodont OraVerse Injection Recall: Impurity Risk in 15-Month Stability Test.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40614-septodont-oraverse-injection-recall-impurity-risk-in-15-month-stability. Based on FDA recall #D-0828-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0828-2018%22&limit=1).
Why it’s dangerous
The product was tested for stability at 15 months, but a known degradation product impurity (Phentolamide) was found. This impurity could potentially cause harm if the product degrades over time.
Who’s affected
Prescription users of OraVerse injections with lot numbers D01894E or D01894G. Patients using the product for dental procedures are most at risk.
How to tell if you have this one
Check the lot number on the OraVerse injection box. Affected lots are D01894E and D01894G. The product is a prescription-only injection sold in boxes of 10 cartridges.
- Brand
Septodont- Category
Drug
What to do — step by step
Check Lot Number
Look for lot numbers D01894E or D01894G on the OraVerse injection box.
Questions people ask
Why is this product being recalled?
Septodont recalled OraVerse injections after finding a known degradation product impurity (Phentolamide) at the 15-month stability test.
What should I do if I have this product?
Check the lot number on the box. If it's D01894E or D01894G, contact Septodont for instructions.
Is this product safe to use?
The product may have degraded over time, but the recall is for potential impurities found during testing, not current safety issues.
Contact Septodont
We’ve drafted a message you can send Septodont to request your refund or repair — edit it as you like.
Subject: Recall D-0828-2018 — Septodont Septodont Hello, I own a Septodont that is covered by recall D-0828-2018 from Septodont. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0828-2018 (April 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0828-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.