3% Polocaine DENTAL — Class II drug recall D-0230-2026
Ongoing recall by Novocol Pharmaceutical of Canada, Inc., reported 2025-12-24, distributed nationwide. Defective container: cracked/broken cartridges
| Recall number | D-0230-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novocol Pharmaceutical of Canada, Inc., Cambridge, Canada |
| Recall initiated | 2025-10-31 |
| Classified | 2025-12-12 |
| Reported by FDA | 2025-12-24 |
| Distributed | Nationwide (US) |
| Quantity | 5,825 |
| Reason classes | packaging |
| NDC | 66312-0441, 66312-0441-16 |
| Lot numbers | D05159C |
| Expiration dates | 2027-07-31 |
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 for recall
Defective container: cracked/broken cartridges
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0230-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.