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

National Drug Code

Is NDC 75834-0257-01 recalled?

Atorvastatin calcium · 1000 TABLET in 1 BOTTLE (75834-257-01)

Yes — this exact package was recalled

1 FDA recall names the code 75834-0257-01 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.

Active ingredient
Atorvastatin calcium
Strength
ATORVASTATIN 40 mg/1
Form
Tablet · Oral
Labeler
Nivagen Pharmaceuticals, INC.
Type
Human Prescription Drug
Product code
75834-0257

Recalls naming this package

Class II ยท Moderate risk

Atorvastatin Calcium Tablets

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

Terminated Particulate / foreign matter Nivagen Pharmaceuticals Inc D-0001-2025

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