Mimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling on certain cartons. The recall affects 218,174 cartons distributed in the United States.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall for mislabeling, a packaging-only/labeling issue with no reported safety hazard or potential for direct harm to patients. Per the rubric, labeling errors without contamination or structural defects are classified as Low severity.
Plain-English summary
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 tablets. The affected product has NDC 0093-5455-28 and was distributed nationwide. The recall was initiated on January 7, 2022, and terminated on June 1, 2023.
The reason for the recall is mislabeling on the cartons. Four specific lot numbers are affected: Lot 100018611 (expiration 03/2022), Lot 100019834 (expiration 06/2022), Lot 100022226 (expiration 09/2022), and Lot 100024574 (expiration 01/2023). A total of 218,174 cartons were distributed.
This is a voluntary recall initiated by the manufacturer. Teva Pharmaceuticals USA notified firms of the recall by letter. Consumers or healthcare providers who have this product should contact their pharmacy or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE)
- Brand
- MIMVEY
- Manufacturer
- Teva Pharmaceuticals USA
- Hazard
- Affected units
- 218,174
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot#: 100018611
- Exp 03/2022
- 100019834
- Exp 06/2022
- 100022226
- Exp 09/2022
- 100024574
- Exp 01/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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