Dr. Reddy's Laboratories, Inc. recalls Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind.
Dr. Reddy's recalls 1000-count Ezetimibe and Simvastatin tablets with black speckles. Consumers should check NDC 43598-586-10 and lot numbers 43E021/43E023 for affected products.
Stop using this now
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Contact the company & request your remedy
What happened, in plain English
Dr. Reddy's recalls 1000-count Ezetimibe and Simvastatin tablets (10mg/80mg) that contain black speckles. This foreign substance could cause harm if ingested, so affected users should stop using the product immediately. Read more at govinfonow.com/recall/39247-dr-reddy-s-ezetimibe-simvastatin-tablets-recall-black-speckles-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/39247-dr-reddy-s-ezetimibe-simvastatin-tablets-recall-black-speckles-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-0389-2019
Cite this page
“Dr. Reddy's Ezetimibe/Simvastatin Tablets Recall: Black Speckles Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39247-dr-reddy-s-ezetimibe-simvastatin-tablets-recall-black-speckles-hazard. Based on FDA recall #D-0389-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0389-2019%22&limit=1).
Why it’s dangerous
The tablets contain visible black speckles, which are foreign substances that could be harmful if ingested. This is a safety issue because the speckles may cause injury or health problems when taken with medication.
Who’s affected
People with prescriptions for these specific tablets, especially those who have already taken the product. Those who purchased the tablets with NDC 43598-586-10 and lot numbers 43E021 or 43E023 are most at risk.
How to tell if you have this one
Check for the NDC code 43598-586-10 on the product label. Look for lot numbers 43E021 or 43E023. The product is sold as a 1000-count bottle for prescription use only.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled tablets if you have them.
Questions people ask
Are these tablets safe to take?
No, the tablets contain black speckles that could be harmful if ingested. Do not take them.
How can I check if my tablets are recalled?
Check the NDC code 43598-586-10 and lot numbers 43E021 or 43E023 on the product label.
What should I do if I have the recalled tablets?
Discard the tablets immediately and contact your doctor for alternative medication.
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-0389-2019 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-0389-2019 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-0389-2019 (January 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0389-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.