Gildess 1/20 — Class III drug recall D-0120-2017
Completed recall by Par Pharmaceutical, Inc., reported 2016-11-09, distributed nationwide. Subpotent Drug; Ethinyl Estradiol
| Recall number | D-0120-2017 |
|---|---|
| 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 | 393,981 tablets |
| Reason classes | potency |
| NDC | 00603-7607-15, 00603-7607-48 |
| Lot numbers | 4101059, 4101062, 4187113, 4187114, 4187115, 4190273, 4190274, 4190280, 4190536, 4265203, 4265204, 4265205, 4359294, 4359296, 4367922, 4379814, 4403535, 4403536, 4501265, 4501267, 4506357, 4563352, 4563353, 4572326, 4572327, 4572328, 4627845, 4651818, 4731571, 4731572, 4731573, 4798704, 4798705, 4936585 |
Product
Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), 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-0120-2017. 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.