Gildess FE 1/20 — Class III drug recall D-0121-2017
Completed recall by Par Pharmaceutical, Inc., reported 2016-11-09, distributed nationwide. Subpotent Drug; Ethinyl Estradiol
| Recall number | D-0121-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Pharmaceutical, Inc., Chestnut Ridge, NY, United States |
| Recall initiated | 2016-09-27 |
| Classified | 2016-11-01 |
| Reported by FDA | 2016-11-09 |
| Distributed | Nationwide (US) |
| Quantity | 822,009 tablets |
| Reason classes | potency |
| NDC | 00603-7609-17 |
| Lot numbers | 4101072, 4101073, 4101074, 4149704, 4152054, 4152056, 4152057, 4159857, 4169950, 4169951, 4187122, 4187123, 4187124, 4187125, 4190275, 4190276, 4190278, 4190279, 4265208, 4265209, 4265210, 4265211, 4265212, 4265213, 4265214, 4265215, 4265216, 4266535, 4266536, 4266537, 4266538, 4266539, 4267686, 4267687, 4267688, 4267689, 4329888, 4334997, 4334998, 4334999 and 55 more |
Product
Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
Reason for recall
Subpotent Drug; Ethinyl Estradiol
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-0121-2017. 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.