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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Estradiol Vaginal Inserts Recalled Due to Defective Tablet Applicators

Agency Publication Date: March 22, 2018
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Summary

Teva Pharmaceuticals USA is recalling approximately 640,486 units of Estradiol Vaginal Inserts (10 mcg) due to a defect in the packaging container. Consumers have reported difficulty dispensing the medication tablet from the applicator provided in the kit. If the tablet cannot be properly released, patients may not receive their intended dose of medication. This recall affects both 8-count and 18-count cartons distributed across the United States and Puerto Rico. You should contact your healthcare provider or pharmacist if you have one of the affected lots.

Risk

A mechanical defect in the applicator prevents the medication tablet from being dispensed properly during use. This can lead to a failure in delivering the required dosage of estradiol, potentially impacting the effectiveness of the treatment.

What You Should Do

  1. Check your medication carton for Estradiol Vaginal Inserts, USP 10 mcg, and look for the following NDC numbers: 0093-3223-08 (8 inserts/carton) or 0093-3223-97 (18 inserts/carton).
  2. For 8-count cartons (NDC 0093-3223-08), check if your package matches any of these lot numbers and expiration dates: 33812545A (Exp. 12/2018), 33812546A (Exp. 12/2018), 33812774A (Exp. 12/2018), 33812775A (Exp. 01/2019), 33812776A (Exp. 05/2019), 33812777A (Exp. 05/2019), 33813786A (Exp. 7/2019), 33813868A (Exp. 7/2019), 33813974A (Exp. 09/2019), 33814058A (Exp. 09/2019), or 33814113A (Exp. 01/2019).
  3. For 18-count cartons (NDC 0093-3223-97), check for these specific lot numbers with an expiration date of 1/2019: 33812547A, 33813361A, or 33813676A.
  4. If your lot number is listed, contact your healthcare provider or pharmacist for guidance on how to continue your treatment and to discuss alternative applicators or replacements.
  5. Return any unused product to your pharmacy for a refund and contact Teva Pharmaceuticals USA for further instructions regarding the defective applicators.
  6. For any additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Estradiol Vaginal Inserts, USP 10 mcg (8 inserts/carton)
Model:
NDC 0093-3223-08
D-0620-2018
Lot Numbers:
33812545A (Exp. 12/2018)
33812546A (Exp. 12/2018)
33812774A (Exp. 12/2018)
33812775A (Exp. 01/2019)
33812776A (Exp. 05/2019)
33812777A (Exp. 05/2019)
33813786A (Exp. 7/2019)
33813868A (Exp. 7/2019)
33813974A (Exp. 09/2019)
33814058A (Exp. 09/2019)
33814113A (Exp. 01/2019)
Date Ranges: Exp. 12/2018, Exp. 01/2019, Exp. 05/2019, Exp. 7/2019, Exp. 09/2019
Product: Estradiol Vaginal Inserts, USP 10 mcg (18 inserts/carton)
Model:
NDC 0093-3223-97
D-0620-2018
Lot Numbers:
33812547A (Exp. 1/2019)
33813361A (Exp. 1/2019)
33813676A (Exp. 1/2019)
Date Ranges: Exp. 1/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79542
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 640,486 vaginal inserts
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.