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OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 car...

FDA Recall #D-0234-2026 — Class II — October 31, 2025

Recall #D-0234-2026 Date: October 31, 2025 Classification: Class II Status: Ongoing

Product Description

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 for Recall

Defective container: cracked/broken cartridges

Recalling Firm

Novocol Pharmaceutical of Canada, Inc. — Cambridge

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1,636 cartons

Distribution

U.S.A. Nationwide

Code Information

Lot: D05004E, expires: 04-30-2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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