Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet
Recalled by ANI Pharmaceuticals, Inc.
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
ANI Pharmaceuticals, Inc. has recalled Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on May 27, 2026 and was initiated on May 12, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, with approximately 3964 Cartons affected. The company behind the recall is ANI Pharmaceuticals, Inc., based in Baudette, MN. The FDA describes the product as: “Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20”
Why was Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet recalled?
According to the FDA, the stated reason for the recall is: “Defective Container; packets were found to be either empty or partially full.”
What should you do?
If you think you may have bought Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, compare it against the product description and identifying codes (Lot M251109, exp Nov 2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact ANI Pharmaceuticals, Inc. or your local health authority.
About this recall
This recall was distributed in MN. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- May 27, 2026
- Recall started
- May 12, 2026
- Distributed in
- MN
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet recalled?+
According to the FDA: Defective Container;
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0543-2026. Information last synced from the FDA on July 5, 2026.