Lupin Pharmaceuticals Inc. recalls Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles,
Lupin Pharmaceuticals recalls 40mg Lovastatin tablets with impurity issues from specific lots. These prescription drugs may contain unsafe levels of impurities affecting safety. Consumers should contact the manufacturer for details.
Recall notice
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Contact the company & request your remedy
What happened, in plain English
Lupin Pharmaceuticals is recalling 40mg Lovastatin tablets that were made with drug substance containing impurities. This could pose a risk to your health if the impurities are not within safe levels. The recall affects specific product lots and packaging. Read more at govinfonow.com/recall/39194-lupin-lovastatin-40mg-tablets-recall-impurity-risk-in-finished-product.
Source Summary by GovInfoNow · govinfonow.com/recall/39194-lupin-lovastatin-40mg-tablets-recall-impurity-risk-in-finished-product · Updated October 5, 2026 · FDA enforcement record: FDA #D-0513-2019
Cite this page
“Lupin Lovastatin 40mg Tablets Recall: Impurity Risk in Finished Product.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39194-lupin-lovastatin-40mg-tablets-recall-impurity-risk-in-finished-product. Based on FDA recall #D-0513-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0513-2019%22&limit=1).
Why it’s dangerous
The drug substance used in manufacturing had impurities that did not meet quality standards. These impurities could potentially affect the safety of the final product when taken by patients. The issue occurred during the manufacturing process, not after the product was distributed.
Who’s affected
Prescription drug users who purchased the specific 40mg Lovastatin tablets with NDC codes 68180-469-07 (60-count) or 68180-469-01 (100-count) from the listed lots. People taking statins for cholesterol management are most at risk.
How to tell if you have this one
Check your prescription bottle for 40mg Lovastatin tablets with NDC codes 68180-469-07 (60-count) or 68180-469-01 (100-count). The lot numbers are G702755 (expiring March 2020) or G702756 (expiring March 2020).
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Identify your bottle's NDC code and lot number to confirm if it's part of the recall.
Questions people ask
Why is this product being recalled?
The drug substance used in manufacturing had impurities that did not meet quality standards, which could affect the safety of the final product.
What should I do if I have this product?
The recall record does not specify a remedy, so contact Lupin Pharmaceuticals directly for instructions.
Are there any safety risks from this product?
The recall indicates potential impurities in the drug substance, but the specific health risks are not detailed in the official notice.
Contact Lupin Pharmaceuticals
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0513-2019 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0513-2019 from Lupin Pharmaceuticals. 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-0513-2019 (February 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0513-2019 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.