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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

Glenmark Pharmaceuticals Inc., USA: Estradiol Vaginal Inserts Recalled for Defective Applicator Delivery System

Agency Publication Date: October 28, 2019
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Summary

Glenmark Pharmaceuticals Inc. is recalling 216,840 cartons of Estradiol Vaginal Inserts USP, 10 mcg, including both 8-count and 18-count packages. The recall was initiated after complaints that the disposable applicators provided with the inserts were difficult to use because the plunger was hard to push. This defect can prevent the medication from being delivered properly or cause frustration and difficulty during administration.

Risk

A defective delivery system means the applicator plunger may fail to move smoothly, which can lead to improper dosing or the inability to use the medication as prescribed. While no specific injuries were reported, the mechanical failure of the applicator prevents the medication from reaching the intended site of action.

What You Should Do

  1. Identify your product by checking the carton for Estradiol Vaginal Inserts USP, 10 mcg with NDC 68462-711-71 (8-count) or NDC 68462-711-88 (18-count).
  2. Verify if your medication is part of the recall by checking the batch numbers: For 8-count cartons, look for batches 20180514, 20180544 (Exp Apr-2020), 20180545, 20180546, 20180588 (Exp May-2020), or 20190003 (Exp Jun-2020).
  3. For 18-count cartons, look for batch numbers 20180515, 20180543 (Exp Apr-2020), or 20180587 (Exp May-2020).
  4. If your product matches these identifiers, contact your healthcare provider or pharmacist for guidance on continuing your treatment.
  5. Return any unused product to the pharmacy where you purchased it for a refund and contact Glenmark Pharmaceuticals Inc. at their Mahwah, NJ location for further instructions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and guidance via pharmacy and healthcare provider.

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-count)
Model:
NDC 68462-711-71
Recall #: D-0156-2020
Lot Numbers:
20180514 (Exp Apr-2020)
20180544 (Exp Apr-2020)
20180545 (Exp May-2020)
20180546 (Exp May-2020)
20180588 (Exp May-2020)
20190003 (Exp Jun-2020)
Date Ranges: Apr-2020, May-2020, Jun-2020
Product: Estradiol Vaginal Inserts USP, 10 mcg (18-count)
Model:
NDC 68462-711-88
Recall #: D-0156-2020
Lot Numbers:
20180515 (Exp Apr-2020)
20180543 (Exp Apr-2020)
20180587 (Exp May-2020)
Date Ranges: Apr-2020, May-2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84071
Status: Resolved
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 216,840 cartons
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.