CLASS II Drug recall · Reported 29 May 2019 · FDA Enforcement Report
Articaine Dental, Articane hydrochloride recalled by Septodont
Septodont is recalling Articaine Dental, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges, distributed nationwide in the US. The recall was initiated on 2 May 2019 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-1307-2019
- FDA event ID
- 82760
- Recalling firm
- Septodont, Louisville, CO
- Brand
- Articadent
- Manufacturer
- Dentsply Pharmaceutical
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2019
- FDA classified
- 28 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Allergy Medication
Timeline
| 2 May 2019 | Recall initiated by company | |
| 28 May 2019 | Classified by FDA | +26 days |
| 29 May 2019 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
Product as listed by the FDA
Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
Which lots are affected?
Lot # D02599A, exp. Sept 2020, D02608B, exp. October 2020
Where was it sold?
Nationwide in the USA
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.
More recalls from Septodont
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | OraVerse (Phentolamine Mesylate) Injection, 0.4 mg recalled by SeptodontOraverse | Septodont | Potency & Assay | CO |