Recall archive / FDA drug enforcement

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Ma... — FDA record D-0521-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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
Reason: Mislabeling
Classification: Class III
Recalling firm: Teva Pharmaceuticals USA
Quantity: 218174 cartons
Agency-reported status: Terminated
Source record identifier: D-0521-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

USA Nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 9, 2022
Recall initiation date: Jan 7, 2022
Center classification date: Feb 2, 2022
Termination date: Jun 1, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.