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Class II · ModerateActive recall

Atorvastatin Calcium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: U24T0408A, Exp: 03/31/2026
Where it was soldNationwide within the U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byUmedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India foreign manufacturer
Brand nameATORVASTATIN CALCIUM
Generic nameATORVASTATIN CALCIUM
Active ingredient(s)ATORVASTATIN
Distributed by / forNivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA
NDC75834-257-01
Show the full FDA record
Full product labelAtorvastatin 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.
Recalling firmNivagen Pharmaceuticals Inc
DistributionNationwide within the U.S
Quantity2328 bottles
Recall initiated2024-09-24
Report date2024-10-09
Recall completed—
Recall numberD-0001-2025
ClassificationClass II
FDA statusOngoing
Origin on fileSacramento CA United States

Related

Atorvastatin recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.