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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Atorvastatin Calcium Tablets Recalled for Impurity and Degradation Issues

Agency Publication Date: March 1, 2021
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Summary

Dr. Reddy's Laboratories is recalling Lipitor (atorvastatin calcium) 40mg tablets in 90-count and 500-count bottles because testing detected impurities and degradation products known as ATV cyclo, Dihydroxy epoxy, and Dieto epoxy. This recall affects approximately 235,150 bottles—specifically 10,440 90-count bottles and 224,710 500-count bottles—distributed nationwide. Consumers should check their prescription bottles to see if their medication is part of the affected lots, which have expiration dates ranging from March 2021 to May 2022. You should contact your pharmacist or healthcare provider to discuss continued use of this medication and how to obtain a safe replacement.

Risk

The tablets failed to meet quality specifications due to the presence of chemical impurities and degradation products that formed over time. Consuming a drug that contains unintended impurities may lead to reduced effectiveness or unforeseen side effects, though this specific recall is classified as a low-risk (Class III) event.

What You Should Do

  1. Check your Atorvastatin Calcium 40mg prescription bottle for the manufacturer name 'Dr. Reddy's Laboratories Limited' and NDC codes 55111-123-90 (90-count) or 55111-123-05 (500-count).
  2. Verify if your bottle matches one of the affected lot numbers, such as T900406 (Exp 3/2021), T000078 through T000088 (Exp 12/2021-1/2022), or T901568 through T901577 (Exp 10/2021-11/2022). A full list of over 100 affected lot codes is available in the product details.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment; do not stop taking your prescribed cholesterol medication without professional guidance as your health condition requires consistent management.
  4. Return any unused portions of the affected medication to your pharmacy to receive a refund and to ensure the product is properly handled.
  5. For further questions regarding this recall, contact Dr. Reddy's Laboratories, Inc. at their Princeton, NJ headquarters or call the FDA Consumer Complaint coordinator at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy 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, 40mg (90-count bottle)
Model:
NDC 55111-123-90
D-0291-2021
Lot Numbers:
T900406 (exp 3/2021)
Date Ranges: Expiration March 2021
Product: Atorvastatin Calcium Tablets, 40mg (500-count bottle)
Model:
NDC 55111-123-05
D-0291-2021
Lot Numbers (99):
T000078 (exp 12/2021)
T000079 (exp 12/2021)
T000080 (exp 12/2021)
T000081 (exp 12/2021)
T000082 (exp 12/2021)
T000083 (exp 12/2021)
T000084 (exp 12/2021)
T000085 (exp 12/2021)
T000086 (exp 12/2021)
T000087 (exp 12/2021)
T000088 (exp 1/2022)
T000311 (exp 1/2022)
T000312 (exp 1/2022)
T000313 (exp 1/2022)
T000314 (exp 1/2022)
T000315 (exp 1/2022)
T000316 (exp 1/2022)
T000317 (exp 1/2022)
T000318 (exp 1/2022)
T000319 (exp 1/2022)
T000320 (exp 1/2022)
T000500 (exp 2/2022)
T000501 (exp 2/2022)
T000502 (exp 2/2022)
T000503 (exp 2/2022)
T000504 (exp 2/2022)
T000505 (exp 2/2022)
T000506 (exp 2/2022)
T000507 (exp 2/2022)
T000508 (exp 2/2022)
T000509 (exp 3/2022)
T000510 (exp 3/2022)
T000647 (exp 3/2022)
T000648 (exp 3/2022)
T000651 (exp 3/2022)
T000652 (exp 3/2022)
T000653 (exp 3/2022)
T000654 (exp 3/2022)
T000875 (exp 4/2022)
T000876 (exp 4/2022)
T000877 (exp 4/2022)
T000878 (exp 4/2022)
T000879 (exp 4/2022)
T000880 (exp 4/2022)
T000881 (exp 4/2022)
T000882 (exp 4/2022)
T000883 (exp 4/2022)
T000884 (exp 4/2022)
T001120 (exp 5/2022)
T001121 (exp 5/2022)
Date Ranges: December 2021 - May 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87365
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Pharmacies nationwide
Manufactured In: India, United States
Units Affected: 10,440 90-count and 224,710 500-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.