Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 66312-0601-16 recalled?

Articadent · 50 CARTRIDGE in 1 CARTON (66312-601-16) / 1.7 mL in 1 CARTRIDGE

Yes — this exact package was recalled

1 FDA recall names the code 66312-0601-16 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Articaine hydrochloride and Epinephrine Bitartrate
Strength
ARTICAINE HYDROCHLORIDE 40 mg/mL; EPINEPHRINE BITARTRATE…
Form
Injection, Solution · Submucosal
Labeler
Dentsply Pharmaceutical
Type
Human Prescription Drug
Product code
66312-0601

Recalls naming this package

Class II · Moderate risk

Articaine DENTAL

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.

Terminated Labeling / mix-up Septodont Inc. NDC 66312-601-16 D-1307-2019

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler