Gildess 24 FE 1 — Class III drug recall D-0123-2017
Completed recall by Par Pharmaceutical, Inc., reported 2016-11-09, distributed nationwide. Subpotent Drug; Ethinyl Estradiol
| Recall number | D-0123-2017 |
|---|---|
| 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 | 44,127 tablets |
| Reason classes | potency |
| NDC | 00603-7610-17, 00603-7610-49 |
| Lot numbers | 4028921, 4082018, 4082019, 4258629, 4359320, 4359321, 4461688, 4461689, 4501285, 4501286, 4501287, 4581736 |
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 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-0123-2017. 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.