Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Atorvastatin Calcium Tablets Recalled for Impurity Specification Failures

Agency Publication Date: May 27, 2021

Summary

Dr. Reddy's Laboratories is voluntarily recalling 2,980 bottles of Atorvastatin Calcium (the generic version of the cholesterol medication Lipitor) in 10 mg strength. The recall was initiated because the tablets failed testing for impurities and degradation specifications, specifically due to the presence of 'ATV cyclo' impurities. These 500-count bottles were distributed nationwide across the United States.

Risk

The tablets contain impurities that exceed approved quality specifications, which may affect the stability or safety of the medication over time. While this is a low-risk (Class III) recall, consuming medication with unauthorized degradation products means the drug does not meet federal quality standards.

What You Should Do

Check your medication bottle to see if it is Atorvastatin Calcium Tablets, USP 10 mg, in a 500-count bottle with NDC 55111-121-05.
Identify the specific affected product by looking for Lot # C905063 with an expiration date of 07/2021.
Contact your healthcare provider or pharmacist immediately to discuss if you should continue taking your current supply or if you need a replacement prescription.
Return any unused tablets from this specific lot to your pharmacy for a refund and to ensure the product is properly handled.
Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office for further instructions regarding this recall.
For additional questions or to report a problem, call 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

Pharmacy refund and healthcare consultation

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, USP 10 mg (500 count bottle)

Model:

NDC 55111-121-05

Lot Numbers:

C905063 (Exp 07/2021)

Date Ranges: Expiration 07/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87879

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 2980 500 count -bottles

Distributed To: Nationwide

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

Risk

What You Should Do

Check your medication bottle to see if it is Atorvastatin Calcium Tablets, USP 10 mg, in a 500-count bottle with NDC 55111-121-05.

Identify the specific affected product by looking for Lot # C905063 with an expiration date of 07/2021.

Contact your healthcare provider or pharmacist immediately to discuss if you should continue taking your current supply or if you need a replacement prescription.

Return any unused tablets from this specific lot to your pharmacy for a refund and to ensure the product is properly handled.

Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office for further instructions regarding this recall.

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