Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Mibelas 24 Fe Birth Control Tablets Recalled for Impurity Specifications

Agency Publication Date: August 13, 2020

Summary

Lupin Pharmaceuticals Inc. is recalling 560,922 pouches of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable birth control. This recall was initiated because an out-of-specification result was observed during testing for related substances, meaning the tablets may contain impurities or have degraded beyond acceptable standards. Consumers who use this medication should contact their healthcare provider or pharmacist for guidance on alternative therapy and how to return the product.

Risk

The presence of impurities or drug degradation can potentially reduce the effectiveness of the hormonal medication or cause unexpected side effects. While no specific injuries have been reported, failed specifications mean the manufacturer cannot guarantee the potency or safety of the drug throughout its shelf life.

What You Should Do

Check your Mibelas 24 Fe packaging for the following affected lot numbers and expiration dates: Lot L900017 (Exp. 12/31/2020), Lot L900070 (Exp. 12/31/2020), Lot L900589 (Exp. 03/31/2021), Lot L901085 (Exp. 04/30/2021), Lot L901008 (Exp. 06/30/2021), Lot L901641 (Exp. 10/31/2021), or Lot L901735 (Exp. 10/31/2021).
Identify the product by the NDC numbers printed on the packaging: NDC 68180-911-11 for a single pouch containing one wallet of 28 tablets, or NDC 68180-911-13 for a carton containing three wallets.
If your medication is part of the recall, contact your healthcare provider or pharmacist immediately to discuss a replacement prescription or alternative birth control methods to avoid unintended pregnancy.
Return any unused or affected product to your pharmacy to receive a refund and further instructions on proper disposal.
Contact Lupin Pharmaceuticals Inc. at their Baltimore, Maryland headquarters if you have specific questions regarding this voluntary recall.
For additional information or to report a side effect, 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

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: Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable, 1 mg/0.02 mg/75 mg (Pouch/1 Wallet)

Model:

NDC: 68180-911-11

Recall #: D-1502-2020

Lot Numbers:

L900017 (Exp. 12/31/2020)

L900070 (Exp. 12/31/2020)

L900589 (Exp. 03/31/2021)

L901085 (Exp. 04/30/2021)

L901008 (Exp. 06/30/2021)

L901641 (Exp. 10/31/2021)

L901735 (Exp. 10/31/2021)

Date Ranges: Exp. 12/31/2020, Exp. 03/31/2021, Exp. 04/30/2021, Exp. 06/30/2021, Exp. 10/31/2021

Product: Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable, 1 mg/0.02 mg/75 mg (Carton/3 Wallets)

Model:

NDC: 68180-911-13

Recall #: D-1502-2020

Lot Numbers:

L900017 (Exp. 12/31/2020)

L900070 (Exp. 12/31/2020)

L900589 (Exp. 03/31/2021)

L901085 (Exp. 04/30/2021)

L901008 (Exp. 06/30/2021)

L901641 (Exp. 10/31/2021)

L901735 (Exp. 10/31/2021)

Date Ranges: Exp. 12/31/2020, Exp. 03/31/2021, Exp. 04/30/2021, Exp. 06/30/2021, Exp. 10/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86108

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Pharmacies nationwide

Manufactured In: India, United States

Units Affected: 560,922 Pouches

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

Risk

What You Should Do

Check your Mibelas 24 Fe packaging for the following affected lot numbers and expiration dates: Lot L900017 (Exp. 12/31/2020), Lot L900070 (Exp. 12/31/2020), Lot L900589 (Exp. 03/31/2021), Lot L901085 (Exp. 04/30/2021), Lot L901008 (Exp. 06/30/2021), Lot L901641 (Exp. 10/31/2021), or Lot L901735 (Exp. 10/31/2021).

Identify the product by the NDC numbers printed on the packaging: NDC 68180-911-11 for a single pouch containing one wallet of 28 tablets, or NDC 68180-911-13 for a carton containing three wallets.

If your medication is part of the recall, contact your healthcare provider or pharmacist immediately to discuss a replacement prescription or alternative birth control methods to avoid unintended pregnancy.

Return any unused or affected product to your pharmacy to receive a refund and further instructions on proper disposal.

Contact Lupin Pharmaceuticals Inc. at their Baltimore, Maryland headquarters if you have specific questions regarding this voluntary recall.

For additional information or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable, 1 mg/0.02 mg/75 mg (Pouch/1 Wallet)

Model:

NDC: 68180-911-11

Recall #: D-1502-2020

Lot Numbers:

L900017 (Exp. 12/31/2020)

L900070 (Exp. 12/31/2020)

L900589 (Exp. 03/31/2021)

L901085 (Exp. 04/30/2021)

L901008 (Exp. 06/30/2021)

L901641 (Exp. 10/31/2021)

L901735 (Exp. 10/31/2021)

Date Ranges: Exp. 12/31/2020, Exp. 03/31/2021, Exp. 04/30/2021, Exp. 06/30/2021, Exp. 10/31/2021

Product: Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable, 1 mg/0.02 mg/75 mg (Carton/3 Wallets)

Model:

NDC: 68180-911-13

Recall #: D-1502-2020

Lot Numbers:

L900017 (Exp. 12/31/2020)

L900070 (Exp. 12/31/2020)

L900589 (Exp. 03/31/2021)

L901085 (Exp. 04/30/2021)

L901008 (Exp. 06/30/2021)

L901641 (Exp. 10/31/2021)

L901735 (Exp. 10/31/2021)

Date Ranges: Exp. 12/31/2020, Exp. 03/31/2021, Exp. 04/30/2021, Exp. 06/30/2021, Exp. 10/31/2021