Use caution Drug recall · FDA · Published May 12, 2026

ANI Pharmaceuticals Recalls Estradiol Gel Due to Defective Containers

ANI Pharmaceuticals recalls Estradiol Gel packets because some are empty or partially full. Check your lot number and expiration date for details.

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

🇺🇸 FDA recall #D-0543-2026Drug ANI Pharmaceuticals ›

Use caution until it’s fixed

Defective Container; packets were found to be either empty or partially full.

Take action

Contact the company

Recalling firmANI Pharmaceuticals, Inc.210 W Main St · Baudette, MN 56623-2467

✎ GovInfoNow plain-language explainer

ANI Pharmaceuticals, Inc. is recalling Estradiol Gel, 0.1%, distributed in cartons of 30 packets. The recall was issued because the containers were found to be defective, with some packets being either empty or partially full. This means patients may not receive the correct dosage of medication. Read more at govinfonow.com/recall/31313-ani-pharmaceuticals-recalls-estradiol-gel-due-to-defective-containers.

Source Summary by GovInfoNow · govinfonow.com/recall/31313-ani-pharmaceuticals-recalls-estradiol-gel-due-to-defective-containers · Updated October 9, 2026 · FDA enforcement record: FDA #D-0543-2026

Cite this page

“ANI Pharmaceuticals Recalls Estradiol Gel Due to Defective Containers.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31313-ani-pharmaceuticals-recalls-estradiol-gel-due-to-defective-containers. Based on FDA recall #D-0543-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0543-2026%22&limit=1).

The FDA announced on May 12, 2026, that ANI Pharmaceuticals is recalling Estradiol Gel packets due to defective containers that may be empty or partially full. The agency issued recall number D-0543-2026 for the voluntary action.

How to tell if you have it

Brand: ANI Pharmaceuticals
Product: Estradiol Gel Packets
Strength: 0.1%, 0.25 mg, 0.25 g per packet
Packaging: 30 packets per carton
NDC: 70954-531-20
Lot code: M251109
Expiration: Nov 2027
Distribution: Nationwide in the USA

The hazard

The recall addresses defective containers, as packets were found to be either empty or partially full. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show ANI Pharmaceuticals has issued three other recalls since October 9, 2020. On June 2, 2026, the company recalled hydrOXYzine oral solution due to a foreign substance. A February 15, 2022 recall involved 0.5mg Alprazolam Tablets because of manufacturing deviations. Other recent recalls of similar products include Keystone Burkhart Anesthetic Gel Recall (May 21, 2026), Keystone Pearson Topical Anesthetic Gel Recall (May 21, 2026), and Keystone Dental City Topical Anesthetic Gel Recall (May 21, 2026).

How to tell if you have this one

Check if you have Estradiol Gel, 0.1%, distributed by ANI Pharmaceuticals, Inc., located in Baudette, MN. Look for NDC 70954-531-20 and Lot number M251109 with an expiration date of November 2027.

Brand
ANI Pharmaceuticals
Category
Drug

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 15 days after the firm started it.

May 12, 2026Firm started the recall
May 20, 2026FDA classified it Class II
May 27, 2026Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How many cartons are affected by this recall?

Approximately 3,964 cartons are included in this recall.

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Link to this recall

<a href="https://govinfonow.com/recall/31313-ani-pharmaceuticals-recalls-estradiol-gel-due-to-defective-containers">ANI Pharmaceuticals Recalls Estradiol Gel Due to Defective Containers (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-0543-2026 (May 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0543-2026 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.