Reported Aug 19, 2020 · Terminated

Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02…

Lupin Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174

Is this the product you have?

  • Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets
  • NDC
    • 68180-911-11
    • Carton contains 3 wallets of 28 tablets each
  • NDC68180-911-13
  • Distributed byLupin Pharmaceuticals, Inc., MD, 21200
  • Manufactured byLupin Limited, India
Lot codes and dates
    • Lot #s: L900017
    • L900070
    • Exp. 12/31/2020
    • L900589
    • Exp. 03/31/2021
    • L901085
    • Exp. 04/30/2021
    • L901008
    • Exp. 06/30/2021
    • L901641
    • L901735
    • Exp.10/31/2021
Amount recalled
560,922 Pouches

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Lupin Pharmaceuticals Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 21, 2022 · Data as of Sep 19, 5:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.