Food, drugs, devices › Mylan Pharmaceuticals Inc.
Drug recall: Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91
FDA enforcement event 81221 is a drug recall by Mylan Pharmaceuticals Inc. of Morgantown, WV, initiated 27 Aug 2018 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 26 Jul 2019. Initiation: voluntary: firm initiated. Mylan Pharmaceuticals Inc. has 55 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mylan Pharmaceuticals Inc., Morgantown, WV.
Reason for recall
"Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs."
Distribution
"Product was distributed throughout the United States."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53. | 5,790 cartons (526,890 tablets) | Class III | Terminated | 24 Oct 2018 |
Context
Other enforcement events for Mylan Pharmaceuticals Inc.
All 55 events for Mylan Pharmaceuticals Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed throughout the United States."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Jul 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.