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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81221

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 27, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Mylan Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-0025-2019
Recall number
D-0025-2019
Initiated
August 27, 2018
Classification
Class III
Status
Terminated
Quantity
5,790 cartons (526,890 tablets)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Not Elsewhere Classified-Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.

Code information

Lot # 8508F004A; Exp. 02/20

Distribution pattern

Product was distributed throughout the United States.