RecallRadar

FDA Drug recall D-0521-2022

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr La…

On 2022-02-09 the FDA classified a Class III recall of Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr La… by Teva Pharmaceuticals Usa, citing mislabeling.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0521-2022
ClassificationClass III
Statusterminated
Initiated2022-01-07
Published2022-02-09
Last updated2026-09-13 11:52 UTC
CompanyTeva Pharmaceuticals Usa
DistributionUS

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

Identifiers

ndc0093-5455-28
ndc0093-5455-42
code_infoLot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023

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-0521-2022%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.