Amneal Estradiol Gel Recall: Defective Empty or Partial Packets
Amneal recalls Estradiol Gel packets due to defective containers that may be empty or partially full. Check your lot number and expiration date.
Use caution until it’s fixed
Defective Container; packets were found to be either empty or partially full.
What happened, in plain English
Amneal Pharmaceuticals is recalling Estradiol Gel, 0.1%, distributed in cartons of 30 Rx-only packets. The hazard stems from defective containers where individual packets were found to be either completely empty or only partially filled with the medication. This means users may not receive the prescribed dose. Read more at govinfonow.com/recall/1443840-amneal-pharmaceuticals-llc-recalls-estradiol-gel-0-1-0-25.
Source Summary by GovInfoNow · govinfonow.com/recall/1443840-amneal-pharmaceuticals-llc-recalls-estradiol-gel-0-1-0-25 · Published October 13, 2026 · Updated October 13, 2026 · FDA enforcement record: FDA #D-0873-2026
Cite this page
“Amneal Estradiol Gel Recall: Defective Empty or Partial Packets.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/1443840-amneal-pharmaceuticals-llc-recalls-estradiol-gel-0-1-0-25. Based on FDA recall #D-0873-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0873-2026%22&limit=1).
Why it’s dangerous
The primary danger is that the defective packaging results in packets containing no gel or less than the intended amount. For a medication like Estradiol Gel, which requires precise dosing for hormonal balance, receiving an empty or partial packet can lead to under-treatment of the condition being managed.
Who’s affected
Patients who have been prescribed Estradiol Gel by Amneal Pharmaceuticals and purchased it nationwide in the USA. Individuals using the specific recalled lot are at risk of receiving an incorrect dosage.
How to tell if you have this one
Check your product for the following details: Brand is Amneal Pharmaceuticals; Product is Estradiol Gel, 0.1%, 0.25 mg in 30-packet cartons; NDC is 69238-2452-3; Lot number is 245226005B; Expiration date is 04/30/2028.
- Brand
Amneal Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Product Details
Verify if your Estradiol Gel packets match the recalled lot number (245226005B) and expiration date (04/30/2028).
Contact Your Pharmacist
If you have the recalled product, contact your pharmacy or healthcare provider to discuss replacement options.
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 published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
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-0873-2026 (September 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0873-2026 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.