American Health Packaging recalls Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC
American Health Packaging recalls 40mg Lovastatin Tablets due to impurities in drug substance. This may affect safety. Check NDC codes 68001-316-00 and 68001-316-08 for affected products.
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
American Health Packaging is recalling 40mg Lovastatin Tablets in 100-count and 1000-count bottles due to impurities in the drug substance. This could pose a safety risk to users. Read more at govinfonow.com/recall/39188-american-health-packaging-lovastatin-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39188-american-health-packaging-lovastatin-tablets-recall-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1584-2019
Cite this page
“American Health Packaging Lovastatin Tablets Recall: Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39188-american-health-packaging-lovastatin-tablets-recall-impurity-risk. Based on FDA recall #D-1584-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1584-2019%22&limit=1).
Why it’s dangerous
The drug substance used in the tablets was found to have impurities that did not meet quality standards. This could potentially affect the safety and effectiveness of the medication.
Who’s affected
People who own or use the recalled Lovastatin Tablets for prescription purposes. Those with specific medical conditions requiring this medication may be at higher risk.
How to tell if you have this one
Check for 40mg Lovastatin Tablets in 100-count bottles (NDC 68001-316-00) or 1000-count bottles (NDC 68001-316-08). These were manufactured by Lupin Limited and distributed by American Health Packaging.
- Brand
American Health Packaging- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC codes 68001-316-00 or 68001-316-08 on the packaging to confirm if your product is affected.
Questions people ask
Why is this product being recalled?
The drug substance used in the tablets was found to have impurities that did not meet quality standards.
What should I do if I have this product?
The official recall notice does not specify a remedy or action for affected products.
Are there any safety risks from this product?
The recall is due to impurities in the drug substance, which could potentially affect safety and effectiveness.
Contact American Health Packaging
We’ve drafted a message you can send American Health Packaging to request your refund or repair — edit it as you like.
Subject: Recall D-1584-2019 — American Health Packaging American Health Packaging Hello, I own a American Health Packaging that is covered by recall D-1584-2019 from American Health Packaging. 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-1584-2019 (February 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1584-2019 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.