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Verified · FDAClass II — Possible RiskMedications

Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only Recall 2026

ESTRADIOLIssued September 8, 2026Updated Reviewed by the Recall Watch editorial team

ESTRADIOL Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3. — recalled per FDA on 9/8/2026. Reason: Defective Container; packets were found to be either empty or partially full..

Agency
FDA
Issued
Sep 8, 2026
Brand
ESTRADIOL
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued September 8, 2026 · Last synced Oct 14, 2026

What's recalled

Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.

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Why it was recalled

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

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot # 245226005B
Exp Date: 04/30/2028.
Where was it sold
1 state

Nationwide in the USA.

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the ESTRADIOL recall still active?

Yes, this recall is currently active as of September 8, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # 245226005B, Exp Date: 04/30/2028.. Check the label on your product.

What should I do if I have the recalled ESTRADIOL?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.