Drug recall: 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton conta
Novocol Pharmaceutical of Canada, Inc. (Cambridge) initiated this drug recall on 31 Oct 2025; FDA lists 7 product records under event 98080, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 79% of the 322 drug enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Novocol Pharmaceutical of Canada, Inc. has 2 enforcement events on this register, with a median of 7 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Novocol Pharmaceutical of Canada, Inc., Cambridge, Canada.
Reason for recall
"Defective container: cracked/broken cartridges"
Distribution
"U.S.A. Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0228-2026 | 2% 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. | 18,789 cartons- 50 cartridges /carton | Class II | Ongoing | 24 Dec 2025 |
| D-0229-2026 | Lidocaine 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,… | 12,033 cartons | Class II | Ongoing | 24 Dec 2025 |
| D-0230-2026 | 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. | 5,825 | Class II | Ongoing | 24 Dec 2025 |
| D-0231-2026 | darby 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. | 5,520 Cartons | Class II | Ongoing | 24 Dec 2025 |
| D-0232-2026 | Benco 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.,… | — | Class II | Ongoing | 24 Dec 2025 |
| D-0233-2026 | Cook-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. | 40 cartons | Class II | Ongoing | 24 Dec 2025 |
| 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 Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10 | 1,636 cartons | Class II | Ongoing | 24 Dec 2025 |
Context
Other enforcement events for Novocol Pharmaceutical of Canada, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Nov 2020 | Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL (86867) | Drug | Class III | 1 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective container: cracked/broken cartridges"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.A. Nationwide"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.