Lower risk Drug recall · FDA · Published December 26, 2018

Glenmark Estradiol Vaginal Inserts Recall: Plunger Malfunction Risk

Glenmark Pharmaceuticals recalls Estradiol Vaginal Inserts (10 mcg) due to customer reports of plunger malfunction in applicators. Affected units have specific NDC numbers and batch dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0350-2019Drug Glenmark ›

Lower-risk recall

Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

Take action

Contact the company

Recalling firmGlenmark Pharmaceuticals Inc., USA750 Corporate Dr · Mahwah, NJ 07430-2009

✎ GovInfoNow plain-language explainer

Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts (10 mcg) because customers report the applicator plunger may malfunction. This could lead to improper hormone delivery if the device doesn't work correctly. Read more at govinfonow.com/recall/39293-glenmark-estradiol-vaginal-inserts-recall-plunger-malfunction-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39293-glenmark-estradiol-vaginal-inserts-recall-plunger-malfunction-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0350-2019

Cite this page

“Glenmark Estradiol Vaginal Inserts Recall: Plunger Malfunction Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39293-glenmark-estradiol-vaginal-inserts-recall-plunger-malfunction-risk. Based on FDA recall #D-0350-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0350-2019%22&limit=1).

The FDA announced on 2018-12-26 that Glenmark Pharmaceuticals Inc., USA is recalling Estradiol Vaginal Inserts, USP, 10 mcg due to a defective delivery system. The agency classified the recall as Class II.

How to tell if you have it

Brand: Glenmark
Product: Estradiol Vaginal Inserts, USP, 10 mcg
NDC 68462-711-71 (8 count)
NDC 68462-711-88 (18 count)
Lot 20180393, exp. 01/31/2020
Lot 20180424, exp. 02/29/2020
Lot 20180425, exp. 02/29/2020
Lot 20180427, exp. 02/29/2020
Lot 20180338, exp. 12/31/2019
Lot 20180386, exp. 01/31/2020

The hazard

The recall addresses customer complaints regarding a malfunctioning plunger of the applicator. The FDA stated that this defect constitutes the hazard for the recalled product.

Context

GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has 54 other recalls on record since 2017-11-20. Other recent recalls of similar products include Glenmark Azelaic Acid Gel 15% Recall (2026-07-23), Glenmark Alyacen Birth Control Tablets Recall (2026-05-27), and Glenmark Ondansetron Tablets Recall (2025-12-30). Other recent recalls of similar products include ANI Pharmaceuticals Recalls Estradiol Gel Due to Defective Containers (2026-05-12), Baxter Vasopressin Injection Recall (2026-08-06), and Teva Octreotide Acetate 30mg Kit (2026-04-24).

How to tell if you have this one

Check for cartons labeled 'Estradiol Vaginal Inserts, USP, 10 mcg, Rx only' with NDC numbers 68462-711-71 (8 count) or 68462-711-88 (18 count). Products from batches listed in the description are affected.

Brand
Glenmark
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the NDC numbers 68462-711-71 or 68462-711-88 on the carton.
Contact Your Doctor
Discuss alternative hormone therapy options with your healthcare provider if you have the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Dec 26, 2018Firm started the recall
Jan 8, 2019FDA classified it Class II
Jan 16, 2019Published in FDA’s Enforcement Report
Oct 6, 2020FDA terminated the recall

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

Similar recalls

Other Glenmark recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/39293-glenmark-estradiol-vaginal-inserts-recall-plunger-malfunction-risk">Glenmark Estradiol Vaginal Inserts Recall: Plunger Malfunction Risk (GovInfoNow)</a>

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-0350-2019 (December 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0350-2019 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.