Septodont Inc. recalls Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only,
Septodont recalls 50-cartridge dental products labeled incorrectly as Articadent Dental, causing confusion with Xylocaine Dental. Mislabeling may lead to incorrect medication use.
Lower-risk 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.
Contact the company & request your remedy
What happened, in plain English
Septodont is recalling dental cartridges that were mislabeled as Articadent Dental when they should be labeled as Articaine Dental. This mislabeling could cause confusion with a different dental anesthetic product, potentially leading to incorrect medication use. Read more at govinfonow.com/recall/38859-septodont-articaine-dental-cartridges-recalled-due-to-mislabeling.
Source Summary by GovInfoNow · govinfonow.com/recall/38859-septodont-articaine-dental-cartridges-recalled-due-to-mislabeling · Updated October 5, 2026 · FDA enforcement record: FDA #D-1307-2019
Cite this page
“Septodont Articaine Dental Cartridges Recalled Due to Mislabeling.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38859-septodont-articaine-dental-cartridges-recalled-due-to-mislabeling. Based on FDA recall #D-1307-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1307-2019%22&limit=1).
Why it’s dangerous
The cartridges were printed on a carton that included text for both Articaine Dental and Xylocaine Dental. This mislabeling could lead to confusion about which medication is being used, potentially causing incorrect administration of a different anesthetic.
Who’s affected
Dentists and dental clinics that purchased these cartridges for use in dental procedures. Patients receiving dental care from these providers may be at risk if the wrong medication is used.
How to tell if you have this one
Check for cartridges labeled as Articadent Dental with NDC 66312-601-16 and lots D02599A (exp. Sept 2020) or D02608B (exp. Oct 2020). These were manufactured by Novocol Pharmaceutical of Canada, Inc. in York, PA.
- Brand
Septodont- Category
Drug
What to do — step by step
Check Product Label
Look for the label 'Articadent Dental' on the carton, which indicates mislabeling.
Questions people ask
Why is this product being recalled?
The product was mislabeled on the carton, causing confusion with another dental anesthetic product. This could lead to incorrect medication use.
Is there a risk of serious injury?
The recall is due to mislabeling, not a safety hazard. There is no risk of serious injury from this product.
How can I tell if I have the recalled product?
Check for cartridges labeled 'Articadent Dental' with NDC 66312-601-16 and lots D02599A (exp. Sept 2020) or D02608B (exp. Oct 2020).
Contact Septodont
We’ve drafted a message you can send Septodont to request your refund or repair — edit it as you like.
Subject: Recall D-1307-2019 — Septodont Septodont Hello, I own a Septodont that is covered by recall D-1307-2019 from Septodont. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1307-2019 (May 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1307-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.