CLASS III Drug recall · Reported 24 Oct 2018 · FDA Enforcement Report
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg recalled
Mylan Pharmaceuticals is recalling Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, distributed nationwide in the US. The recall was initiated on 27 Aug 2018 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-0025-2019
- FDA event ID
- 81221
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Aug 2018
- FDA classified
- 14 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 27 Aug 2018 | Recall initiated by company | |
| 14 Oct 2018 | Classified by FDA | +48 days |
| 24 Oct 2018 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Product as listed by the FDA
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Which lots are affected?
Lot # 8508F004A; Exp. 02/20
Where was it sold?
Product was distributed throughout the United States.
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.
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|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
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| 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 Levonorgestrel recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levonorgestrel and Ethinyl Estradiol Tablets recalled | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Altavera Levonorgestrel and Ethinyl Estradiol Tablets recalledAltavera | Xiromed | Labeling Errors | Nationwide |
| Drug | CLASS II | Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive recalledOption 2 | L. Perrigo | Other | Nationwide |
| Drug | CLASS III | Lessina(R) (Levonorgestrel and ethinyl estradiol tablets recalledLessina | Teva Pharmaceuticals USA | Benzene | Nationwide |
| Drug | CLASS III | Portia (levonorgestrel and ethinyl estradiol) Tablets recalledPortia | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |