Biocon Pharma Recalls Atorvastatin Tablets Nationwide for Quality Concerns

Source: FDA Enforcement Report

Biocon Pharma Inc. has issued a nationwide voluntary recall of Atorvastatin Calcium Tablets USP 40 mg (Lot #AVC24035) after the product failed dissolution testing, meaning it may not release the active ingredient properly in the body.

What’s Being Recalled

• Product: Atorvastatin Calcium Tablets USP 40 mg

• Quantity: 1000-count bottles

• NDC: 70377-079-13

• Lot Number: AVC24035 (Exp. 03/31/26)

• Classification: Class II Recall (potential for temporary or reversible health effects)

• Distribution: U.S. nationwide

• Manufacturer: Recipharm Pharmaservices Pvt. Ltd., Bengaluru, India

• Recalling Firm: Biocon Pharma Inc., Iselin, New Jersey

Why the Recall Matters

Atorvastatin — commonly known as the generic form of Lipitor — is used to lower cholesterol and reduce the risk of heart attack and stroke. A failure to dissolve properly could mean patients don’t receive the full therapeutic benefit, potentially leaving cholesterol levels uncontrolled and heart disease risks elevated.

No injuries or adverse events have been reported to date, but patients should check their medication bottles and contact their pharmacy if they believe they have the affected lot.

What Patients Should Do

• Stop taking the affected product only after consulting your doctor or pharmacist.

• Check the lot number on your prescription label or bottle (Lot: AVC24035).

• Contact Biocon Pharma for more information about replacement or return options.

Legal and Safety Context

At KBD Attorneys, we believe patients deserve safe, effective medications — not hidden risks or manufacturing errors. Our firm closely tracks FDA drug recalls and pharmaceutical safety alerts to keep consumers informed and protected. If you or someone you love has been harmed by a defective or dangerous drug, our attorneys are here to help you seek justice and accountability. We fight to hold negligent manufacturers responsible and to ensure families have the resources they need to recover.

Our team has written extensively about recalls involving contaminated, defective, and misformulated medications — including recent cases where manufacturing lapses led to reduced effectiveness or hidden side effects.

If you or a loved one experienced harm from a defective prescription drug, KBD Attorneys can help you understand your legal rights and next steps. Contact us today.