CLASS II ONGOING Drug recall · Reported 24 Dec 2025 · FDA Enforcement Report
Cook-Walte, Carbocaine 3% (30 mg/mL) recalled
Novocol Pharmaceutical of Canada is recalling Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), distributed nationwide in the US. The recall was initiated on 31 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0233-2026
- FDA event ID
- 98080
- Recalling firm
- Novocol Pharmaceutical of Canada, Cambridge
- Brand
- Carbocaine
- Manufacturer
- Septodont, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Oct 2025
- FDA classified
- 12 Dec 2025
- Reported
- 24 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 31 Oct 2025 | Recall initiated by company | |
| 12 Dec 2025 | Classified by FDA | +42 days |
| 24 Dec 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: cracked/broken cartridges
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Defective container: cracked/broken cartridges
Which lots are affected?
Lot: D05159I, expires: 07-31-2027
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 98080This product is part of a recall event; the main page for the event is Benco dental Graham Chemical CO., Mepivacaine HCI recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Benco dental Graham Chemical CO., Mepivacaine HCI recalledMepivacaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide | |
| CLASS II | darby dental supply, Mepivacaine, Mepivacaine HCI recalledMepivacaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide | |
| CLASS II | 3% Polocaine Dental, Mepivacaine Hydrochloride 3% (30mg/mL) recalledPolocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide | |
| CLASS II | 2% Xylocaine Dental with Epinephrine 1:100 recalledXylocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide | |
| CLASS II | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg recalledOraverse | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide | |
| CLASS II | Lidocaine HCI 2% and Epinephrine 1:100 recalledLidocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
More recalls from Novocol Pharmaceutical of Canada
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine HCI 2% and Epinephrine 1:100 recalledLidocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg recalledOraverse | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | 2% Xylocaine Dental with Epinephrine 1:100 recalledXylocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | 3% Polocaine Dental, Mepivacaine Hydrochloride 3% (30mg/mL) recalledPolocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | darby dental supply, Mepivacaine, Mepivacaine HCI recalledMepivacaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
Other Mepivacaine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 3% Polocaine Dental, Mepivacaine Hydrochloride 3% (30mg/mL) recalledPolocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | darby dental supply, Mepivacaine, Mepivacaine HCI recalledMepivacaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | Benco dental Graham Chemical CO., Mepivacaine HCI recalledMepivacaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS III | Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without recalledScandonest 3% Plain | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | Mepivacaine HCL/epinephrine recalled by Franck's Lab Inc., d.b.a. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |