RecallRadar
Free Check
SeptodontdrugHigh PriorityActive

OraVerse Defect Recall

OraVerse has been recalled due to defective components in the packaging. This recall primarily affects healthcare facilities, hospitals, and pharmacies. Individual consumers are unlikely to have this product at home. Check the official FDA notice for specific lot numbers and return or disposal instructions.

By RecallRadar Editorial Team

Sourced from FDA. Last verified March 4, 2026.

On this page

Free checker

Check if you qualify

See whether your device may qualify for a free repair or replacement program before you spend money.

Check if you qualify

Key facts

Date announced
October 31, 2025
Source agency
FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

OraVerse has been recalled due to defective components in the packaging. This recall primarily affects healthcare facilities, hospitals, and pharmacies. Individual consumers are unlikely to have this product at home. Check the official FDA notice for specific lot numbers and return or disposal instructions.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

Defective container: cracked/broken cartridges

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Septodont
Category
drug
Source agency
FDA
Announced
October 31, 2025
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot: D05004E, expires: 04-30-2027

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1## 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 Agency: FDA | Category: drug Reason: Defective container: cracked/broken cartridges What to do:
  2. 2Stop using the product if your lot/model matches.
  3. 3Check the FDA notice for specifics.
  4. 4Follow remedy instructions.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
October 31, 2025
Last reviewed by RecallRadar
March 4, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Lot: D05004E, expires: 04-30-2027.

What is the remedy for this recall?

## 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 Agency: FDA | Category: drug Reason: Defective container: cracked/broken cartridges What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: Septodont recall hub and Food & Drug recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

See an inaccuracy?

Help us improve the accuracy of this recall information.

500 characters remaining

Related Recalls

Chloraprep one-step
High PriorityActive

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

Jul 22, 2026

Cleviprex
High PriorityActive

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.

Lack of Assurance of Sterility

Jul 22, 2026

Quality choice earwax removal kit
High PriorityActive

QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Jul 22, 2026

Clinere ear wax remover
High PriorityActive

Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Jul 22, 2026

Leader earwax removal kit earwax removal aid and bulb
High PriorityActive

LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Jul 22, 2026