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Lower risk Drug recall · FDA · Published June 3, 2019

Glenmark Estradiol Vaginal Inserts Recall: Defective Plunger May Not Function Properly

Glenmark Pharmaceuticals recalls Estradiol Vaginal Inserts USP 10 mcg (box of 8) due to defective plunger that may not function properly. This is a prescription-only product with specific lot and expiration details.

🇺🇸 FDA recall #D-1340-2019DrugGlenmark ›
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Recalling firmGlenmark Pharmaceuticals Inc., USA750 Corporate Dr · Mahwah, NJ 07430-2009
✎ GovInfoNow plain-language explainer

What happened, in plain English

Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts USP 10 mcg (box of 8) because the plunger may not function properly. This could lead to improper medication delivery, but the recall does not specify a risk of serious injury or harm. Read more at govinfonow.com/recall/38731-glenmark-estradiol-vaginal-inserts-recall-defective-plunger-may-not-function.

Source Summary by GovInfoNow · govinfonow.com/recall/38731-glenmark-estradiol-vaginal-inserts-recall-defective-plunger-may-not-function · Updated October 5, 2026 · FDA enforcement record: FDA #D-1340-2019

Cite this page

“Glenmark Estradiol Vaginal Inserts Recall: Defective Plunger May Not Function Properly.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38731-glenmark-estradiol-vaginal-inserts-recall-defective-plunger-may-not-function. Based on FDA recall #D-1340-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1340-2019%22&limit=1).

Why it’s dangerous

The plunger in the Estradiol Vaginal Inserts may not function properly, which could lead to improper medication delivery. This defect is specific to the packaging and does not involve immediate safety risks like injury or death.

Who’s affected

Prescription users of Estradiol Vaginal Inserts USP 10 mcg (box of 8) with the specific lot number 20180516. Women who have been prescribed this medication are most at risk.

How to tell if you have this one

Check for the product name 'Estradiol Vaginal Inserts USP 10 mcg', packaged in a box of 8 with disposable applicators. Look for the lot number 20180516 and expiration date 4/30/2020 on the packaging.

  • Brand
    Glenmark
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number 20180516 and expiration date 4/30/2020 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

1. Firm started the recall: Jun 3, 201912. FDA classified it Class II: Jun 11, 201923. Published in FDA’s Enforcement Report: Jun 19, 201934. FDA terminated the recall: May 2, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1340-2019 (June 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1340-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA