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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Kaitlib Fe Chewable Tablets Recalled for Failed Impurity Stability Tests

Agency Publication Date: July 30, 2019
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Summary

Lupin Pharmaceuticals Inc. has recalled approximately 12,938 units of Kaitlib Fe (norethindrone and ethinyl estradiol) chewable birth control tablets. The recall was issued because the medication failed to meet purity and degradation standards during a long-term stability study. Using medication that has degraded or contains impurities may lead to reduced effectiveness or unexpected side effects. Consumers who have this prescription medication should consult their doctor or pharmacist immediately for guidance and a replacement.

Risk

The product exceeded specified limits for impurities or degradation products over time, which means the chemical composition of the tablets has changed. This can compromise the drug's intended potency and safety profile, potentially impacting the effectiveness of the birth control.

What You Should Do

  1. Check your medication packaging for Kaitlib Fe (norethindrone and ethinyl estradiol chewable tablets, 0.8 mg/0.025 mg) and Ferrous Fumarate chewable tablets.
  2. Specifically look for Lot number L800050 on the wallet or carton to see if your supply is affected.
  3. Verify the National Drug Codes (NDC) on the packaging: NDC 68180-903-11 for a single wallet of 28 tablets or NDC 68180-903-13 for a carton containing 3 wallets.
  4. Contact your healthcare provider or pharmacist immediately to discuss using an alternative form of birth control and to obtain a replacement prescription.
  5. Return any unused tablets from Lot L800050 to your pharmacy for a refund and further instructions on proper disposal.
  6. For additional questions or to report adverse effects, contact Lupin Pharmaceuticals at the information provided on your prescription or contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets (Wallet of 28)
Model:
NDC 68180-903-11
Lot Numbers:
L800050
Product: Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets (Carton of 3 wallets)
Model:
NDC 68180-903-13
Lot Numbers:
L800050

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83284
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 12938 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.