CLASS III Drug recall · Reported 31 May 2017 · FDA Enforcement Report
Norethindrone Acetate and Ethinyl Estradiol Tablets recalled
Mylan Pharmaceuticals is recalling Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack, distributed nationwide in the US. The recall was initiated on 30 Jan 2017 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-0861-2017
- FDA event ID
- 77065
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Jan 2017
- FDA classified
- 23 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 30 Jan 2017 | Recall initiated by company | |
| 23 May 2017 | Classified by FDA | +113 days |
| 31 May 2017 | 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
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
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
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.
Where it was distributed
Nationwide in USA
Questions about this recall
Why was it recalled?
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Which lots are affected?
Lot #: 6327A006, Exp 02/18
Where was it sold?
Nationwide in USA
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
1 other product · FDA event 77065| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Tarina Fe 1/20 (Norethindrone Acetate recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Norethindrone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Nortrel 7/7/7 (norethindrone recalled by Teva Pharmaceuticals USANortrel 7/7/7 | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 recalledNortrel | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Balziva 28 Day (norethindrone recalled by Cardinal HealthBalziva | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS I | Taytulla Softgel Capsules, 1 mg/20 mcg recalled by Allergan, PLCTaytulla | Allergan | Other | Nationwide |