Medications & Supplements/Prescription Drugs

Atorvastatin Calcium Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: March 28, 2025

Summary

Biocon Pharma Inc. is recalling approximately 2,184 bottles of Atorvastatin Calcium (40 mg), a prescription medication used to treat high cholesterol. The recall was initiated because the tablets failed dissolution testing, meaning they released the active ingredient more slowly than required. If you are taking this medication, please consult your doctor or pharmacist to determine if your supply is affected and to obtain a replacement.

Risk

When a medication fails dissolution specifications, it may not be properly absorbed by the body. This can lead to the drug being less effective at lowering cholesterol, potentially resulting in poorly managed heart health for the patient.

What You Should Do

This recall affects Atorvastatin Calcium Tablets USP 40 mg packaged in 1000-count bottles with NDC 70377-079-13.
Identify if your medication is affected by checking the bottle for lot number AVC24035 and an expiration date of 03/31/26.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Biocon Pharma Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Atorvastatin Calcium Tablets USP 40 mg (1000-count bottle)

Variants: 40 mg, Tablet

Lot Numbers:

AVC24035 (Exp 03/31/26)

NDC:

70377-079-13

Manufactured by Recipharm Pharmaservices PVT, Ltd Bengaluru, India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96496

Status: Active

Manufacturer: BIOCON PHARMA INC

Manufactured In: India, United States

Units Affected: 2184 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Atorvastatin Calcium Tablets USP 40 mg packaged in 1000-count bottles with NDC 70377-079-13.

Identify if your medication is affected by checking the bottle for lot number AVC24035 and an expiration date of 03/31/26.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Biocon Pharma Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.