Mibelas 24 Fe — Class II drug recall D-1502-2020
Terminated recall by Lupin Pharmaceuticals Inc., reported 2020-08-19, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
| Recall number | D-1502-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2020-07-21 |
| Classified | 2020-08-13 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2022-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 560,922 pouches |
| Reason classes | specification failure |
| NDC | 68180-0911-11, 68180-0911-13 |
| Lot numbers | L900017, L900070, L900589, L901008, L901085, L901641, L901735 |
| Expiration dates | 2020-12-31, 2021-03-31, 2021-04-30, 2021-06-30, 2021-10-31 |
Product
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, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1502-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.