CLASS III Drug recall · Reported 9 Nov 2016 · FDA Enforcement Report
Gildess 1/20 (norethindrone acetate, 1 mg recalled by Par Pharmaceutical
Par Pharmaceutical is recalling Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), distributed nationwide in the US. The recall was initiated on 27 Sep 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0120-2017
- FDA event ID
- 75455
- Recalling firm
- Par Pharmaceutical, Chestnut Ridge, NY
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 27 Sep 2016
- FDA classified
- 1 Nov 2016
- Reported
- 9 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 27 Sep 2016 | Recall initiated by company | |
| 1 Nov 2016 | Classified by FDA | +35 days |
| 9 Nov 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug; Ethinyl Estradiol
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug; Ethinyl Estradiol
Which lots are affected?
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
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 75455This product is part of a recall event; the main page for the event is Gildess FE 1/20 (norethindrone acetate, 1 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Gildess FE 1/20 (norethindrone acetate, 1 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide | |
| CLASS III | Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide | |
| CLASS III | Gildess 1.5/30 (norethindrone acetate, 1.5 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide | |
| CLASS III | Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide |
More recalls from Par Pharmaceutical
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | BusPIRone Hydrochloride Tablets, USP 7.5 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Tablets, USP 1 mg recalled by Par Pharmaceutical | Par Pharmaceutical | Potency & Assay | NY |
| Drug | CLASS III | PrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisone | Par Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Frovatriptan Succinate Tablets, 2.5mg recalled by Par Pharmaceutical | Par Pharmaceutical | Labeling Errors | Nationwide |
| Drug | CLASS I | Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate Mofetil | Par Pharmaceutical | Particulate Matter | Nationwide |