FDA Drug recall D-0123-2017
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28…
- FDA Drug
- Class III
- completed
- Published 2016-11-09
On 2016-11-09 the FDA classified a Class III recall of Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28… by Par Pharmaceutical, citing subpotent Drug; Ethinyl Estradiol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0123-2017 |
| Classification | Class III |
| Status | completed |
| Initiated | 2016-09-27 |
| Published | 2016-11-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Par Pharmaceutical |
| Distribution | US |
Product
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Reason
Subpotent Drug; Ethinyl Estradiol
Identifiers
| code_info | Lot Numbers (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286 (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0123-2017%22
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