FDA Recall D-0234-2026

Novocol Pharmaceutical of Canada, Inc.

Class II Ongoing 195 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot: D05004E, expires: 04-30-2027

Quantity: 1,636 cartons

Reason for recall

Defective container: cracked/broken cartridges

Recall record

Recall number: D-0234-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S.A. Nationwide
Recall initiated: 2025-10-31
Classified by FDA Center: 2025-12-12
FDA published: 2025-12-24
Recalling firm: Novocol Pharmaceutical of Canada, Inc.

Drug identification

Brand name(s): ORAVERSE
Generic name(s): PHENTOLAMINE MESYLATE
Manufacturer(s): Septodont, Inc.
NDC(s): 0362-0101
Route(s): SUBMUCOSAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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