Articaine DENTAL — Class II drug recall D-1307-2019

Terminated recall by Septodont Inc., reported 2019-05-29, distributed nationwide. Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used

Recall number	`D-1307-2019`
Product type	Drug
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Septodont Inc., Louisville, CO, United States
Recall initiated	2019-05-02
Classified	2019-05-28
Reported by FDA	2019-05-29
Terminated	2020-11-19
Distributed	Nationwide (US)
Reason classes	labeling
NDC	`66312-0601`, `66312-0601-16`, `66312-0602`, `66312-0602-16`
Lot numbers	`D02599A`, `D02608B`
Expiration dates	`2020-09-20`, `2020-10-20`

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1307-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.