FDA Drug recall D-1502-2020
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Prov…
- FDA Drug
- Class II
- terminated
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class II recall of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Prov… by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1502-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-21 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1502-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.