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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#: AVC24035, Exp 03/31/26
Where it was soldU.S.A. nationwide
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

Failed dissolution specifications: lower than specifications

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 byRecipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123 foreign manufacturer
Brand nameATORVASTATIN CALCIUM
Generic nameATORVASTATIN CALCIUM
Active ingredient(s)ATORVASTATIN CALCIUM TRIHYDRATE
Distributed by / forBiocon Pharma Inc., Iselin, NJ 08830-3009 USA
NDC70377-079-13
Show the full FDA record
Full product labelAtorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
Recalling firmBIOCON PHARMA INC
DistributionU.S.A. nationwide
Quantity2184 bottles
Recall initiated2025-03-17
Report date2025-04-09
Recall completed—
Recall numberD-0306-2025
ClassificationClass II
FDA statusOngoing
Origin on fileISELIN NJ 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.