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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89368

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 07, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Teva Pharmaceuticals USA

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

2 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 2

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28

D-0521-2022
Recall number
D-0521-2022
Initiated
January 07, 2022
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
218174 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeling

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Mislabeling

Code information

Lot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023

Distribution pattern

USA Nationwide

drug · product 2 of 2

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42

D-0522-2022
Recall number
D-0522-2022
Initiated
January 07, 2022
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
6430 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeling

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Mislabeling

Code information

Lot#: 100018610, Exp 03/2022; 100021521, Exp 09/2022; 100024575, Exp 01/2023

Distribution pattern

USA Nationwide