Reported Apr 9, 2025 · Ongoing

Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ…

Biocon Pharma Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BIOCON PHARMA INC · 485 HWY 1 (S) · ISELIN, NJ · 08830

Is this the product you have?

    • Atorvastatin Calcium Tablets USP 40 mg
    • 1000-count bottle
    • Rx Only
  • Manufactured forBiocon Pharma Inc., Iselin, NJ 08830-3009 USA
  • Manufactured byRecipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
Lot codes and dates
    • Lot#: AVC24035
    • Exp 03/31/26
Amount recalled
2184 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed dissolution specifications: lower than specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:54 PM UTC

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