Nivagen Pharmaceuticals Atorvastatin Calcium Tablets Recall

Why it was recalled

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.

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #: U24T0408A, Exp: 03/31/2026

Where it was sold

Nationwide within the U.S

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0001-2025
Classification: Class II
Status: Terminated
Recall initiated: Sep 24, 2024
FDA report date: Oct 9, 2024
Quantity: 2328 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Nivagen Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-0001-2025, exactly as published.

Show all FDA fields

City: Sacramento
State: CA
Status: Terminated
Country: United States
Event ID: 95418
Address: 3100 Fite Cir
Code information: Lot #: U24T0408A, Exp: 03/31/2026
Postal code: 95827-1805
Report date: Oct 9, 2024
Product type: Drugs
Recall number: D-0001-2025
Classification: Class II
Recalling firm: Nivagen Pharmaceuticals Inc
Product quantity: 2328 bottles
Termination date: Jul 1, 2026
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.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: Nationwide within the U.S
Recall initiation date: Sep 24, 2024
Initial firm notification: E-Mail
Center classification date: Oct 2, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0001-2025, published Oct 9, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.