Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Atorvastatin Calcium Tablets USP 40 mg Recalled by BIOCON PHARMA INC Due to Failed dissolution specifications: lower than specifications

Date: March 17, 2025
Company: BIOCON PHARMA INC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact BIOCON PHARMA INC directly.

Affected Products

Atorvastatin 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

Quantity: 2184 bottles

Why Was This Recalled?

Failed dissolution specifications: lower than specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About BIOCON PHARMA INC

BIOCON PHARMA INC has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report