CLASS II Drug recall · Reported 5 Mar 2025 · FDA Enforcement Report
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets recalled by Padagis US
Padagis US is recalling Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per, distributed nationwide in the US. The recall was initiated on 6 Feb 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0246-2025
- FDA event ID
- 96245
- Recalling firm
- Padagis US, Minneapolis, MN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 6 Feb 2025
- FDA classified
- 21 Feb 2025
- Reported
- 5 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 6 Feb 2025 | Recall initiated by company | |
| 21 Feb 2025 | Classified by FDA | +15 days |
| 5 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Which lots are affected?
Lot # 193109; Exp. 07/31/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Estradiol recalls
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg per packet, 30 packets recalledEstradiol | ANI Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Estradiol, 6 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol, 22 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol, 18 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol,15 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |