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Recall Enforment Report D-0230-2026

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Novocol Pharmaceutical of Canada, Inc., originally initiated on 10-31-2025 for the 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. The product was recalled due to defective container: cracked/broken cartridges. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0230-202610-31-202512-24-2025Class II5,8253% 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.Defective container: cracked/broken cartridgesOngoing
D-0232-202610-31-202512-24-2025Class IIBenco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.Defective container: cracked/broken cartridgesOngoing
D-0231-202610-31-202512-24-2025Class II5,520 Cartonsdarby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.Defective container: cracked/broken cartridgesOngoing
D-0234-202610-31-202512-24-2025Class II1,636 cartonsOraVerse, (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 0362-0101-10Defective container: cracked/broken cartridgesOngoing
D-0233-202610-31-202512-24-2025Class II40 cartonsCook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.Defective container: cracked/broken cartridgesOngoing
D-0229-202610-31-202512-24-2025Class II12,033 cartonsLidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.Defective container: cracked/broken cartridgesOngoing
D-0228-202610-31-202512-24-2025Class II18,789 cartons- 50 cartridges /carton2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine 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 66312-176-16.Defective container: cracked/broken cartridgesOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0362-0101Oraverse Phentolamine MesylateInjection, SolutionSubmucosalSeptodont, Inc.Human Prescription Drug
0362-0753Carbocaine Mepivacaine HydrochlorideInjection, SolutionSubmucosalSeptodont, Inc.Human Prescription Drug
50227-1030Lidocaine Lidocaine Hydrochloride And Epinephrine BitartrateInjection, SolutionSubmucosalPatterson DentalHuman Prescription Drug
66312-176Xylocaine Lidocaine Hydrochloride And Epinephrine BitartrateInjection, SolutionSubmucosalDentsply PharmaceuticalHuman Prescription Drug
66312-181Xylocaine Lidocaine Hydrochloride And Epinephrine BitartrateInjection, SolutionSubmucosalDentsply PharmaceuticalHuman Prescription Drug
66312-441Polocaine Mepivacaine HydrochlorideInjection, SolutionSubmucosalDentsply PharmaceuticalHuman Prescription Drug
66467-9760Mepivacaine Mepivacaine HydrochlorideInjection, SolutionSubmucosalDarby Dental Supply, LlcHuman Prescription Drug
66975-406Mepivacaine Mepivacaine HydrochlorideInjection, SolutionSubmucosalBenco DentalHuman Prescription Drug