FDA Drug recall D-0234-2026
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 Ca…
- FDA Drug
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of 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 Ca… by Novocol Pharmaceutical, citing defective container: cracked/broken cartridges.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0234-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-31 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novocol Pharmaceutical |
| Distribution | US |
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
Identifiers
| ndc | 0362-0101-10 |
|---|---|
| code_info | Lot: D05004E, expires: 04-30-2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0234-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.