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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 Malfunctioning Applicator Plunger

Agency Publication Date: January 8, 2019
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Summary

Glenmark Pharmaceuticals Inc., USA is recalling 96,240 units of Estradiol Vaginal Inserts (10 mcg) due to reports that the applicator's delivery system is defective. Specifically, consumers have reported that the plunger on the applicator is malfunctioning, which may prevent the medication from being delivered correctly. This recall affects both 8-count and 18-count cartons distributed to retailers and distributors across the United States. If you have this medication, you should contact your doctor or pharmacist for guidance on your treatment and how to handle the defective device.

Risk

The malfunctioning plunger prevents the medication from being properly administered, which could result in a patient not receiving their prescribed dose. While no specific injuries were mentioned, the defect directly impacts the delivery of the drug therapy.

What You Should Do

  1. Check your medication packaging for Estradiol Vaginal Inserts, USP, 10 mcg, in either 8-count (NDC 68462-711-71) or 18-count (NDC 68462-711-88) cartons.
  2. For 8-count cartons, look for batch numbers 20180393 (Exp. 01/31/2020), 20180424 (Exp. 02/29/2020), 20180425 (Exp. 02/29/2020), or 20180427 (Exp. 02/29/2020).
  3. For 18-count cartons, look for batch numbers 20180338 (Exp. 12/31/2019) or 20180386 (Exp. 01/31/2020).
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment if you have an affected product with a malfunctioning applicator.
  5. Return any unused product to the pharmacy where it was purchased for a refund and contact Glenmark Pharmaceuticals Inc., USA for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product to pharmacy.

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
Lot Numbers:
20180393 (Exp. 01/31/2020)
20180424 (Exp. 02/29/2020)
20180425 (Exp. 02/29/2020)
20180427 (Exp. 02/29/2020)
Date Ranges: Exp. 01/31/2020, Exp. 02/29/2020
Product: Estradiol Vaginal Inserts, USP, 10 mcg (18 count)
Model:
NDC 68462-711-88
Lot Numbers:
20180338 (Exp. 12/31/2019)
20180386 (Exp. 01/31/2020)
Date Ranges: Exp. 12/31/2019, Exp. 01/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81876
Status: Resolved
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: retailers; distributors
Manufactured In: India, United States
Units Affected: 96,240 applicators
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.