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

Is NDC 0527-1231-01 recalled?

Primidone · 100 TABLET in 1 BOTTLE (0527-1231-01)

Yes — this exact package was recalled

1 FDA recall names the code 0527-1231-01 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 250 mg/1
Form
Tablet · Oral
Labeler
Lannett Company, Inc.
Type
Human Prescription Drug
Product code
0527-1231

Recalls naming this package

Class III ยท Low risk

Primidone Tablets USP

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Ongoing Cross-contamination Lannett Company Inc. NDC 0527-1231-01 D-0533-2026

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

  • 0527-1632 See recall 3
  • 0527-0597 See recall 1
  • 0527-0762 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1
  • 0527-0790 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1
  • 0527-1116 See recall 1
  • 0527-1324 See recall 1