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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Lipitor (atorvastatin) Recalled for Failed Impurity Specifications

Agency Publication Date: February 1, 2018
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Summary

Dr. Reddy's Laboratories is recalling 75,645 bottles of Lipitor (atorvastatin calcium) tablets, a medication used to lower cholesterol. This recall affects the 10 mg, 20 mg, and 40 mg strengths in both 90-count and 500-count bottles. The medication was recalled because long-term stability testing showed the levels of certain impurities and degradation products exceeded safe approved limits, which means the drug's quality cannot be guaranteed over time. Consumers should check their prescription bottles immediately to see if their medication is part of this nationwide recall.

Risk

The drug failed testing because total degradation impurities were found at levels higher than specified during stability checks. While this is a low-risk recall, using a medication with excessive degradation products may result in reduced effectiveness or unintended side effects, as the chemical composition has changed from its original approved form.

What You Should Do

  1. Check your prescription bottle label for the product name Atorvastatin Calcium Tablets and the manufacturer Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA.
  2. For 10 mg tablets, identify affected bottles by checking for NDC 55111-121-05 and lot numbers T600125 (Exp 3/2018), T600201 (Exp 5/2018), or T600248 (Exp 5/2018).
  3. For 20 mg tablets, identify affected bottles by checking for NDC 55111-122-05 and lot numbers T600126 (Exp 3/2018), T600202 (Exp 5/2018), or T600247 (Exp 5/2018).
  4. For 40 mg tablets, identify affected 90-count bottles by checking for NDC 55111-123-05 and lot number T600279 (Exp 6/2018).
  5. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription; do not stop taking your cholesterol medication without consulting a professional.
  6. Return any unused portion of the recalled medication to your pharmacy for a refund and contact Dr. Reddy's Laboratories at 1-888-375-3339 for further instructions.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Drug Refund and Guidance

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 10 mg (90 count and 500 count bottles)
Model:
NDC 55111-121-05
Lot Numbers:
T600125 (Exp 3/2018)
T600201 (Exp 5/2018)
T600248 (Exp 5/2018)
Date Ranges: March 2018, May 2018
Product: Atorvastatin Calcium Tablets 20 mg (90 count and 500 count bottles)
Model:
NDC 55111-122-05
Lot Numbers:
T600126 (Exp 3/2018)
T600202 (Exp 5/2018)
T600247 (Exp 5/2018)
Date Ranges: March 2018, May 2018
Product: Atorvastatin Calcium Tablets 40 mg (90 count bottles)
Model:
NDC 55111-123-05
Lot Numbers:
T600279 (Exp 6/2018)
Date Ranges: June 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79065
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 3 products (a) 34,125; b) 3,540 bottles; a) 28,941 and b) 2,928 bottles; 12,579 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.