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

Is NDC 55253-0801-30 recalled?

Modafinil · 30 TABLET in 1 BOTTLE (55253-801-30)

Yes — this exact package was recalled

1 FDA recall names the code 55253-0801-30 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
Modafinil
Strength
MODAFINIL 100 mg/1
Form
Tablet · Oral
Labeler
Cima Labs INC.
Type
Human Prescription Drug · DEA CIV
Product code
55253-0801

Recalls naming this package

Class II ยท Moderate risk

MODAFINIL Tablet

Labeling:Label Mixup; MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD21859_1, EXP: 10/31/2013.

Terminated Labeling / mix-up Aidapak Services, LLC D-623-2014

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.