Par Pharmaceutical Gildess FE 1/20: Subpotent Ethinyl Estradiol Risk
Par Pharmaceutical recalls Gildess FE 1/20 birth control pills due to subpotent ethinyl estradiol content. This may cause ineffective contraception. Affected units have specific lot numbers and NDC codes.
Lower-risk recall
Subpotent Drug; Ethinyl Estradiol
Contact the company
What happened, in plain English
Par Pharmaceutical is recalling Gildess FE 1/20 birth control pills because they contain less active ethinyl estradiol than labeled. This could lead to ineffective contraception. People using these pills should consult their doctor for alternatives. Read more at govinfonow.com/recall/42311-par-pharmaceutical-gildess-fe-1-20-subpotent-ethinyl-estradiol-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42311-par-pharmaceutical-gildess-fe-1-20-subpotent-ethinyl-estradiol-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0121-2017
Cite this page
“Par Pharmaceutical Gildess FE 1/20: Subpotent Ethinyl Estradiol Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42311-par-pharmaceutical-gildess-fe-1-20-subpotent-ethinyl-estradiol-risk. Based on FDA recall #D-0121-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0121-2017%22&limit=1).
Why it’s dangerous
The pills contain subpotent ethinyl estradiol, meaning the active ingredient is less concentrated than intended. This could result in the birth control being less effective, potentially leading to unintended pregnancy. The issue is not life-threatening but affects contraceptive reliability.
Who’s affected
Women who have been prescribed Gildess FE 1/20 birth control pills with the listed lot numbers and NDC codes. Those most at risk are individuals using the medication without medical supervision.
How to tell if you have this one
Check the product label for the NDC code 0603-7609-17 and lot numbers listed in the recall (e.g., 4101072, 4101073, etc.). The pills are 28-count, 6-bottle packs sold by prescription in Canada and the US.
- Brand
Par Pharmaceutical- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Completed- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0119-2017 | Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811; Lot Numbers (a) 4169949, 4297235, 4359298, 4501268, 4614353 (b) 4101064, 4196576, 4228443, 4265206, 4265207, 4267685, 4365281, 4365284, 4365289, 4501276, 4563354, 4563355, 4614354, 4731574, 4731575, 4793332, 4798708, 4798709 | 221,017 tablets |
| D-0120-2017 | 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; Lot Numbers (a) 4101059, 4101062, 4190536, 4265205, 4359294, 4501265, 4572326, 4651818, 4731571, 4798704 (b) 4187113, 4187114, 4187115, 4190273, 4190274, 4190280, 4265203, 4265204, 4359296, 4367922, 4379814, 4403535, 4403536, 4501267, 4506357, 4563352, 4563353, 4572327, 4572328, 4627845, 4731572, 4731573, 4798705, 4936585 | 393,981 tablets |
| D-0121-2017 | 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; 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, 4359303, 4359304, 4359305, 4359306, 4359307, 4359308, 4362141, 4362142, 4362143, 4362144, 4362145, 4365282, 4367923, 4367924, 4367925, 4367926, 4367927, 4367928, 4367929, 4467392, 4467393, 4467394, 4467395, 4482870, 4487638, 4501269, 4501270, 4506358, 4563356, 4563357, 4563358, 4563359, 4563360, 4563361, 4572329, 4572331, 4572332, 4572333, 4583326, 4614355, 4614356, 4614357, 4615487, 4696445, 4696446, 4698118, 4731576, 4731577, 4731578, 4731579, 4731580, 4798710, 4798711, 4798712, 4798713 | 822,009 tablets |
| 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 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; 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 | 278,406 tablets |
| 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 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; Lot Numbers (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286 (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736 | 44,127 tablets |
What to do — step by step
Check Product Label
Look for the NDC code 0603-7609-17 and lot numbers from the list provided in the recall.
Consult Doctor
Talk to your healthcare provider about alternative birth control options if you have been using the recalled pills.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 43 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there any safety risks from using these pills?
The recall is for effectiveness, not safety. The pills do not pose a risk of serious injury or death but may lead to unintended pregnancy if used without medical supervision.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0121-2017 (September 27, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0121-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.