Teva Estradiol Vaginal Inserts Recall: Difficulty dispensing tablets
Teva Pharmaceuticals USA recalls Estradiol Vaginal Inserts (10 mcg) due to difficulty dispensing tablets from the applicator. Affected lots and packaging details provided.
Lower-risk recall
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA is recalling Estradiol Vaginal Inserts (10 mcg) because users report trouble getting the tablets out of the applicator. This could lead to improper use or missed doses if the product doesn't dispense correctly. Read more at govinfonow.com/recall/40774-teva-estradiol-vaginal-inserts-recall-difficulty-dispensing-tablets.
Source Summary by GovInfoNow · govinfonow.com/recall/40774-teva-estradiol-vaginal-inserts-recall-difficulty-dispensing-tablets · Updated October 7, 2026 · FDA enforcement record: FDA #D-0620-2018
Cite this page
“Teva Estradiol Vaginal Inserts Recall: Difficulty dispensing tablets.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40774-teva-estradiol-vaginal-inserts-recall-difficulty-dispensing-tablets. Based on FDA recall #D-0620-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0620-2018%22&limit=1).
Why it’s dangerous
The applicator's design causes difficulty in dispensing the tablet, which may result in improper use or missed doses. This could affect treatment effectiveness but does not pose an immediate safety risk like injury or death.
Who’s affected
Women prescribed estradiol vaginal inserts for medical treatment. Those with specific lot numbers and packaging details listed in the recall are most at risk.
How to tell if you have this one
Check for packaging with 8 inserts/carton (NDC 0093-3223-08) or 18 inserts/carton (NDC 0093-3223-97). Look for specific lot numbers listed in the recall details.
- Brand
Teva- Category
Drug
What to do — step by step
Check Product Details
Review the packaging for the lot numbers and NDC codes listed in the recall to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed within the United States and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- 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-0620-2018 (March 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0620-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.