Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

National Drug Code

Is NDC 0054-0011-25 recalled?

Flecainide Acetate · 100 TABLET in 1 BOTTLE (0054-0011-25)

Yes — this exact package was recalled

1 FDA recall names the code 0054-0011-25 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
flecainide acetate
Strength
FLECAINIDE ACETATE 100 mg/1
Form
Tablet · Oral
Labeler
Hikma Pharmaceuticals USA Inc.
Type
Human Prescription Drug
Product code
0054-0011

Recalls naming this package

Class II · Moderate risk

Flecainide Acetate

Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC 59762045001, Pedigree: AD56847_1, EXP: 5/21/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-788-2014

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.

Other recalled products from this labeler