Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Blisovi Fe Oral Contraceptive Recalled for Crumbling Tablets

Agency Publication Date: January 3, 2020

Summary

Lupin Pharmaceuticals Inc. has recalled approximately 41,863 cartons of Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol) birth control tablets. The recall was initiated because the tablets may crumble or break when being removed from the blister pack. Consumers with affected packs should contact their doctor or pharmacist immediately to ensure they do not miss any doses of their medication.

Risk

If the tablets crumble when removed from the packaging, users may not receive the full intended dose of the medication, which could reduce the effectiveness of the oral contraceptive.

What You Should Do

Check your medication packaging for Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg) with NDC number 68180-866-11.
Identify if your product is from Lot H801227 with an expiration date of January 2020.
If you have an affected lot, contact your healthcare provider or pharmacist for guidance on obtaining a replacement and to ensure your contraceptive coverage is maintained.
Return any unused or defective product to your pharmacy for a refund and contact Lupin Pharmaceuticals Inc. for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg)

Model:

NDC 68180-866-11

Recall #: D-0638-2020

Lot Numbers:

H801227 (Exp. January 2020)

Date Ranges: January 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84571

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 41,863 cartons/3 wallets per carton

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 · 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.

Summary

What You Should Do

Check your medication packaging for Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg) with NDC number 68180-866-11.

Identify if your product is from Lot H801227 with an expiration date of January 2020.

If you have an affected lot, contact your healthcare provider or pharmacist for guidance on obtaining a replacement and to ensure your contraceptive coverage is maintained.

Return any unused or defective product to your pharmacy for a refund and contact Lupin Pharmaceuticals Inc. for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.