FDA Drug recall D-0230-2026
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dos…
- FDA Drug
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dos… by Novocol Pharmaceutical, citing defective container: cracked/broken cartridges.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0230-2026 |
| 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
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.
Reason
Defective container: cracked/broken cartridges
Identifiers
| ndc | 66312-441-16 |
|---|---|
| code_info | Lot: D05159C, expires: 07-31-2027 |
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-0230-2026%22
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