Lupin Pharmaceuticals Inc. recalls Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and
Lupin Pharmaceuticals recalls Fayosim birth control tablets due to impurities detected in stability testing. These tablets may contain harmful substances that could cause serious health risks if used.
Recall notice
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
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What happened, in plain English
Lupin Pharmaceuticals is recalling Fayosim birth control tablets because tests found impurities that could be harmful. This recall affects specific tablet strengths and packaging. Using these tablets may pose a risk of serious health issues due to the impurities. Read more at govinfonow.com/recall/39072-lupin-fayosim-birth-control-tablets-recall-impurities-risk-serious-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/39072-lupin-fayosim-birth-control-tablets-recall-impurities-risk-serious-harm · Updated October 5, 2026 · FDA enforcement record: FDA #D-1057-2019
Cite this page
“Lupin Fayosim Birth Control Tablets Recall: Impurities Risk Serious Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39072-lupin-fayosim-birth-control-tablets-recall-impurities-risk-serious-harm. Based on FDA recall #D-1057-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1057-2019%22&limit=1).
Why it’s dangerous
The tablets were tested for impurities over a 12-month period, but results showed unexpected levels of harmful substances. These impurities could potentially cause serious health issues if the tablets are used as intended.
Who’s affected
Women who have been prescribed Fayosim birth control tablets with the specific strengths and packaging described in the recall notice are affected. Those using the recalled tablets without medical supervision are at risk.
How to tell if you have this one
Check for Fayosim tablets labeled with 0.15 mg/0.02 mg, 0.15 mg/0.025 mg, or 0.15 mg/0.03 mg. The packaging includes a pouch with 91 tablets per carton (NDC 68180-860-11) or a single pouch (NDC 68180-860-12).
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Verify the tablet strength and packaging to confirm if your product is recalled.
Questions people ask
Are these tablets safe to use?
The recall indicates potential impurities detected in stability testing, but the official notice does not specify if the tablets are safe to use.
What should I do if I have the recalled tablets?
The recall notice does not provide specific instructions for action, so contact Lupin Pharmaceuticals for guidance.
How can I confirm if my tablets are recalled?
Check the product details including tablet strength (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, or 0.15 mg/0.03 mg) and packaging (NDC 68180-860-11 or 68180-860-12).
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-1057-2019 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-1057-2019 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-1057-2019 (March 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1057-2019 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.