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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 Due to Defective Plunger Delivery System

Agency Publication Date: June 11, 2019
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Summary

Glenmark Pharmaceuticals Inc., USA is recalling 31,656 boxes of Estradiol Vaginal Inserts USP 10 mcg, a prescription medication used to treat certain symptoms of menopause. The recall was initiated because the plunger in the disposable applicator delivery system is not functioning properly, which can prevent the medication from being administered correctly. Consumers who have this medication should check their packaging for specific lot numbers and expiration dates to determine if their product is part of this nationwide recall.

Risk

The defective delivery system prevents the plunger from working correctly, which may lead to an inability to dispense the medication or incorrect dosing. Because this is a delivery system failure for a prescription drug, you should consult a healthcare professional to ensure your treatment is not interrupted.

What You Should Do

  1. Check your medication box for Estradiol Vaginal Inserts USP 10 mcg with NDC 68462-711-71.
  2. Locate the lot number on the packaging and verify if it matches lot number 20180516 with an expiration date of 4/30/2020.
  3. If your product is affected, contact your healthcare provider or pharmacist for guidance on how to continue your treatment and to obtain a functioning replacement.
  4. Return any unused boxes from this specific lot to your pharmacy for a refund.
  5. Contact Glenmark Pharmaceuticals Inc., USA at their Mahwah, New Jersey headquarters for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

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 (Box of 8 Vaginal Inserts)
Model:
NDC 68462-711-71
Recall #: D-1340-2019
Lot Numbers:
20180516 (Exp 4/30/2020)
Date Ranges: Expiration date 4/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83019
Status: Resolved
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Pharmacies
Manufactured In: United States, India
Units Affected: 31,656 boxes
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.