FDA Drug recall D-0025-2019
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made…
- FDA Drug
- Class III
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class III recall of Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made… by Mylan Pharmaceuticals, citing labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0025-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-27 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
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
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Identifiers
| code_info | Lot # 8508F004A; Exp. 02/20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0025-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.