FDA Drug recall D-0122-2017
Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 bl…
- FDA Drug
- Class III
- completed
- Published 2016-11-09
On 2016-11-09 the FDA classified a Class III recall of Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 bl… by Par Pharmaceutical, citing subpotent Drug; Ethinyl Estradiol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0122-2017 |
| 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 FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, 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: 4169952, 4169953, 4169954, 4185520, 4187127, 4190281, 4228446, 4258626, 4258627, 4279364, 4279365, 4279…Lot Numbers: 4169952, 4169953, 4169954, 4185520, 4187127, 4190281, 4228446, 4258626, 4258627, 4279364, 4279365, 4279366, 4279369, 4359310, 4365283, 4365285, 4365286, 4365287, 4365288, 4379816, 4379817, 4479997, 4501273, 4501274, 4501275, 4563362, 4563363, 4563364, 4614359, 4614360, 4614361 |
|---|
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-0122-2017%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.