Teva Mimvey 1mg/0.5mg Tablets Recalled Due to Mislabeling
Teva Pharmaceuticals USA recalls Mimvey (estradiol and norethindrone acetate) 1 mg/0.5 mg tablets due to mislabeling. Affected lots expire 03/2022 to 01/2023. No remedy specified in recall notice.
Lower-risk recall
Mislabeling
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) 1 mg/0.5 mg tablets because of mislabeling. This could lead to incorrect dosing if the product is used without proper identification. Read more at govinfonow.com/recall/35394-teva-mimvey-1mg-0-5mg-tablets-recalled-due-to-mislabeling.
Source Summary by GovInfoNow · govinfonow.com/recall/35394-teva-mimvey-1mg-0-5mg-tablets-recalled-due-to-mislabeling · Updated August 18, 2026 · FDA enforcement record: FDA #D-0522-2022
Cite this page
“Teva Mimvey 1mg/0.5mg Tablets Recalled Due to Mislabeling.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35394-teva-mimvey-1mg-0-5mg-tablets-recalled-due-to-mislabeling. Based on FDA recall #D-0522-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0522-2022%22&limit=1).
Why it’s dangerous
Mislabeling means the product may not be correctly identified, which could lead to incorrect dosing if the patient takes the tablets without knowing the right dosage. This is a labeling issue that affects prescription safety.
Who’s affected
Prescription patients who have the specific lot numbers of Mimvey tablets (100018610, 100021521, 100024575) from the listed expiration dates. Patients using the product without proper identification may face incorrect dosing.
How to tell if you have this one
Check the lot number on the carton: 100018610 (expires 03/2022), 100021521 (expires 09/2022), or 100024575 (expires 01/2023). The product is a prescription-only tablet with NDC 0093-5455-42.
- Brand
Teva Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
USA Nationwide- NDC
0093-5455-28, 0093-5455-42
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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 Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28; Lot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023 | 218174 cartons |
| D-0522-2022 | 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; Lot#: 100018610, Exp 03/2022; 100021521, Exp 09/2022; 100024575, Exp 01/2023 | 6430 cartons |
What to do — step by step
Check Product Lot Number
Look for the lot numbers 100018610, 100021521, or 100024575 on the carton to determine if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0522-2022 (January 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0522-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.