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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.: Atorvastatin Calcium Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: August 14, 2018
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Summary

Dr. Reddy's Laboratories is recalling 2,280 bottles of Atorvastatin Calcium (generic Lipitor) 40 mg tablets. During stability testing at the 18-month mark, the tablets were found to have levels of impurities and degradation products that exceeded approved safety specifications. This recall affects the 500-count bottles distributed nationwide across the United States. Consumers should contact their doctor or pharmacist for guidance regarding their medication and return any unused product to their pharmacy for a refund.

Risk

The tablets contain higher levels of chemical impurities than allowed by safety standards, which means the medication may not meet quality expectations over its full shelf life and could potentially cause unintended side effects or reduced effectiveness.

What You Should Do

  1. Check your prescription bottle to see if it is Atorvastatin Calcium tablets, 40 mg, in a 500-count bottle with NDC number 55111-123-05.
  2. Identify if your bottle belongs to the affected batch by looking for lot number T60045 on the label.
  3. If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss continuing your treatment or obtaining a replacement prescription.
  4. Do not stop taking your medication until you have spoken with a healthcare professional, as suddenly stopping cholesterol-lowering medication can have health risks.
  5. Return any remaining tablets from the affected lot to the pharmacy where you purchased them for a refund.
  6. Contact Dr. Reddy's Laboratories at 1-888-723-3332 if you have additional questions regarding this recall.
  7. For further consumer safety information, contact the FDA at 1-888-SAFEFDA (1-888-723-3332) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmaceutical guidance and 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, 40 mg (500-count bottle)
Model:
NDC 55111-123-05
Recall #: D-1079-2018
Lot Numbers:
T60045

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80675
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: pharmacies; healthcare providers
Manufactured In: India, United States
Units Affected: 2280 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 ยท 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.