Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Atorvastatin Calcium Tablets Recalled for Foreign Substance Contamination

Agency Publication Date: June 15, 2018

Summary

Dr. Reddy's Laboratories, Inc. has recalled approximately 6,397 bottles of Atorvastatin Calcium (the generic equivalent of Lipitor) 80 mg tablets. This recall was initiated after a consumer reported finding a single tablet with a foreign object embedded inside it. These prescription medications were distributed in 90-count bottles throughout the United States. Consumers who have this medication should contact their healthcare provider or pharmacist for guidance and to arrange for a replacement.

Risk

A tablet containing an embedded foreign object poses a risk of choking or internal injury if swallowed. Additionally, the presence of a foreign substance indicates a potential manufacturing defect that could compromise the safety of the medication.

What You Should Do

Check your prescription bottle label to see if you have Atorvastatin Calcium Tablets, 80 mg, in a 90-count bottle with NDC 55111-124-90 and UPC 355111124900.
Verify if your bottle belongs to the affected lot: look for lot number T800064 with an expiration date of 12/2019.
Contact your healthcare provider or pharmacist immediately for guidance. Do not stop taking your prescribed medication until you have a replacement or have spoken with a medical professional.
Return any unused tablets from the affected lot to the pharmacy where they were purchased for a refund.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return to pharmacy for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Atorvastatin Calcium Tablets, 80 mg (90-count bottle)

Model:

NDC 55111-124-90

UPC Codes:

355111124900

Lot Numbers:

T800064 (Exp 12/2019)

Date Ranges: Expiration 12/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80208

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies nationwide

Manufactured In: India, United States

Units Affected: 6,397 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

Check your prescription bottle label to see if you have Atorvastatin Calcium Tablets, 80 mg, in a 90-count bottle with NDC 55111-124-90 and UPC 355111124900.

Verify if your bottle belongs to the affected lot: look for lot number T800064 with an expiration date of 12/2019.

Contact your healthcare provider or pharmacist immediately for guidance. Do not stop taking your prescribed medication until you have a replacement or have spoken with a medical professional.

Return any unused tablets from the affected lot to the pharmacy where they were purchased for a refund.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.