Lupin Pharmaceuticals Inc. recalls Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable
Lupin Pharmaceuticals recalls Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets due to impurities found in stability testing. This may cause serious health risks. Consumers should contact the company for details.
Recall notice
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Contact the company & request your remedy
What happened, in plain English
Lup: Lupin Pharmaceuticals is recalling Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate chewable tablets because they failed stability testing, which could lead to harmful impurities. This recall affects people using these prescription birth control and iron supplements. Read more at govinfonow.com/recall/38467-lupin-kaitlib-fe-tablets-recall-impurities-risk-serious-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/38467-lupin-kaitlib-fe-tablets-recall-impurities-risk-serious-harm · Updated October 5, 2026 · FDA enforcement record: FDA #D-1565-2019
Cite this page
“Lupin Kaitlib Fe Tablets Recall: Impurities Risk Serious Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38467-lupin-kaitlib-fe-tablets-recall-impurities-risk-serious-harm. Based on FDA recall #D-1565-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1565-2019%22&limit=1).
Why it’s dangerous
The tablets failed stability testing, meaning impurities may have formed over time. This could lead to harmful substances in the product, though the exact health risk isn't specified in the recall notice.
Who’s affected
People who have prescription Kaitlib Fe tablets or Ferrous Fumarate chewable tablets from Lupin Pharmaceuticals. Those using these products for birth control or iron supplementation are most at risk.
How to tell if you have this one
Check for NDC codes 68180-903-11 (28 tablets) or 68180-903-13 (3 wallets) in the product packaging. The tablets are prescription-only and distributed by Lupin Pharmaceuticals.
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Lupin Pharmaceuticals for specific instructions on handling the recalled product.
Questions people ask
Why is this product being recalled?
The product failed stability testing, showing impurities that could pose health risks.
What should I do if I have this product?
Contact Lupin Pharmaceuticals for specific instructions on handling the recalled product.
Is this product safe to use?
The recall indicates potential impurities, but the exact risk isn't specified. Do not use until instructed by the manufacturer.
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-1565-2019 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-1565-2019 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-1565-2019 (July 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1565-2019 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.