Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam -
Dr. Reddy's recalls 40mg Atorvastatin Calcium tablets (500-count) due to impurity issues detected at 18 months. Consumers should check NDC 55111-123-05 for affected products.
Recall notice
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Contact the company & request your remedy
What happened, in plain English
Dr. Reddy's is recalling 40mg Atorvastatin Calcium tablets in 500-count bottles because testing found impurities at 18 months. This could pose a risk to health if the impurities are harmful. Read more at govinfonow.com/recall/39830-dr-reddy-s-atorvastatin-40mg-tablets-recall-impurity-risk-in.
Source Summary by GovInfoNow · govinfonow.com/recall/39830-dr-reddy-s-atorvastatin-40mg-tablets-recall-impurity-risk-in · Updated October 6, 2026 · FDA enforcement record: FDA #D-1079-2018
Cite this page
“Dr. Reddy's Atorvastatin 40mg Tablets Recall: Impurity Risk in 500-count Bottles.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39830-dr-reddy-s-atorvastatin-40mg-tablets-recall-impurity-risk-in. Based on FDA recall #D-1079-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1079-2018%22&limit=1).
Why it’s dangerous
The recall is due to impurities in the medication that were detected during stability testing at 18 months. These impurities could potentially be harmful if they affect the medication's safety.
Who’s affected
People who have the 40mg Atorvastatin Calcium tablets (500-count) from Dr. Reddy's Laboratories in India, NDC 55111-123-05. Those with prescription for this medication are most at risk.
How to tell if you have this one
Check for the product name 'Atorvastatin Calcium tablets, 40 mg, 500-count bottle' with NDC 55111-123-05. The product was manufactured in India by Dr. Reddy's Laboratories Limited.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 55111-123-05 on the bottle label to confirm if your product is affected.
Questions people ask
Why is this medication being recalled?
The recall is due to impurities detected in the medication during stability testing at 18 months.
What should I do if I have this product?
The official recall notice does not specify a remedy or action for affected products.
Is this product safe to use?
The recall indicates potential impurities, but the official notice does not state if the product is safe to use.
Contact Dr. Reddy's
We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.
Subject: Recall D-1079-2018 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-1079-2018 from Dr. Reddy's. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1079-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1079-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.