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Drug FDA Class II Ongoing Foreign material

Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.

Nivagen Pharmaceuticals Inc Published Oct 9, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Nivagen Pharmaceuticals Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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.

Hazards

Carbamazepine Extended-Release 400 mg tablet · primary

Affected products (1)

Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.

ATORVASTATIN CALCIUM · 2328 bottles

NDC: 75834-255, 75834-256, 75834-257, 75834-258, 75834-256-90, 75834-256-01, 75834-256-05, 75834-256-50, 75834-255-90, 75834-255-01, 75834-255-05, 75834-255-50, 75834-257-90, 75834-257-50, 75834-257-25, 75834-257-01, 75834-258-90, 75834-258-50, 75834-258-02, 75834-258-01
Code info: Lot #: U24T0408A, Exp: 03/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 24, 2024
  2. Published
    Oct 9, 2024
Recall number
D-0001-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.