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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Mimvey (Estradiol and Norethindrone Acetate) Tablets Recalled for Mislabeling

Agency Publication Date: February 3, 2022
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Summary

Teva Pharmaceuticals USA is voluntarily recalling 224,604 cartons of Mimvey (estradiol and norethindrone acetate) tablets because the products were mislabeled. Mimvey is a prescription hormone replacement therapy used to treat symptoms of menopause. No incidents or injuries have been reported to date, but the medication was distributed to pharmacies nationwide across the United States.

Risk

The mislabeling of these prescription tablets could cause confusion regarding dosage or administration instructions, which may result in a patient taking the medication incorrectly. While the recall is considered low risk, patients should verify their medication with their healthcare provider to ensure they are using the correct product.

What You Should Do

  1. This recall affects Mimvey (estradiol and norethindrone acetate) tablets, 1 mg/0.5 mg, which are packaged in 28-count cartons and sold under NDCs 0093-5455-28 and 0093-5455-42.
  2. Check the NDC number and lot number printed on your medication carton to determine if your product is affected. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Mimvey (estradiol and norethindrone acetate tablets USP), 28-count carton
Variants: 1 mg/0.5 mg, Rx only
Lot Numbers:
100018611 (Exp 03/2022)
100019834 (Exp 06/2022)
100022226 (Exp 09/2022)
100024574 (Exp 01/2023)
NDC:
0093-5455-28

Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454

Product: Mimvey (estradiol and norethindrone acetate tablets USP), 28-count carton
Variants: 1 mg/0.5 mg, Rx only
Lot Numbers:
100018610 (Exp 03/2022)
100021521 (Exp 09/2022)
100024575 (Exp 01/2023)
NDC:
0093-5455-42

Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89368
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (218174 cartons; 6430 cartons)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.