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

Is NDC 53746-0544-01 recalled?

Primidone · 100 TABLET in 1 BOTTLE (53746-544-01)

Yes — this exact package was recalled

1 FDA recall names the code 53746-0544-01 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.

1 of these recalls is still ongoing.

Active ingredient
Primidone
Strength
PRIMIDONE 50 mg/1
Form
Tablet · Oral
Labeler
Amneal Pharmaceuticals of New York LLC
Type
Human Prescription Drug
Product code
53746-0544

Recalls naming this package

Class III ยท Low risk

Primidone Tablets

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Ongoing Cross-contamination Amneal Pharmaceuticals, LLC D-0585-2026

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