Levonorgestrel and Ethinyl Estradiol Tablets — Class III drug recall D-0025-2019
Terminated recall by Mylan Pharmaceuticals Inc., reported 2018-10-24, distributed nationwide. Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
| Recall number | D-0025-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2018-08-27 |
| Classified | 2018-10-14 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2019-07-26 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 00378-7281-53 |
| Lot numbers | 02/20, 8508F004A |
Product
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.
Reason for recall
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
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-0025-2019. 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.