Glenmark Estradiol Vaginal Inserts Recall: Difficulty Pushing Plunger
Glenmark Pharmaceuticals recalls Estradiol Vaginal Inserts (10 mcg) due to difficulty pushing the plunger of the applicator. This is a drug recall for Rx-only products with specific batch numbers and NDC codes.
Lower-risk recall
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Contact the company
What happened, in plain English
Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts (10 mcg) because users report difficulty pushing the plunger of the applicator. This issue may cause improper use, but the recall does not indicate a risk of serious injury or death. Read more at govinfonow.com/recall/37806-glenmark-estradiol-vaginal-inserts-recall-difficulty-pushing-plunger.
Source Summary by GovInfoNow · govinfonow.com/recall/37806-glenmark-estradiol-vaginal-inserts-recall-difficulty-pushing-plunger · Updated October 5, 2026 · FDA enforcement record: FDA #D-0156-2020
Cite this page
“Glenmark Estradiol Vaginal Inserts Recall: Difficulty Pushing Plunger.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37806-glenmark-estradiol-vaginal-inserts-recall-difficulty-pushing-plunger. Based on FDA recall #D-0156-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0156-2020%22&limit=1).
Why it’s dangerous
The applicator's plunger is difficult to push, which could lead to improper medication delivery. However, the recall does not mention any risk of serious injury or death in normal use.
Who’s affected
Women prescribed Estradiol Vaginal Inserts (10 mcg) by a doctor. Those with the specific batch numbers and NDC codes listed in the recall are most at risk.
How to tell if you have this one
Check the product label for the NDC codes 68462-711-71 (8-count) or 68462-711-88 (18-count). Also, look for batch numbers from the lists provided in the recall.
- Brand
Glenmark- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC codes 68462-711-71 or 68462-711-88 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What batch numbers are affected?
Batch numbers for 8-count inserts: 20180514, 20180544 (Apr-2020), 20180545, 20180546, 20180588 (May-2020), 20190003 (Jun-2020). Batch numbers for 18-count inserts: 20180515, 20180543 (Apr-2020), 20180587 (May-2020).
Do I need to stop using this product?
The recall does not require stopping use; it only addresses difficulty in pushing the plunger.
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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-0156-2020 (October 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0156-2020 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.