CLASS II ONGOING Drug recall · Reported 7 Oct 2026 · FDA Enforcement Report
Estradiol Gel, 0.1%, 0.25 mg, 30-packets recalled
Amneal Pharmaceuticals is recalling Estradiol Gel, 0.1%, 0.25 mg, 30-packets per, distributed nationwide in the US. The recall was initiated on 8 Sep 2026 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-0873-2026
- FDA event ID
- 99742
- Recalling firm
- Amneal Pharmaceuticals, Bridgewater, NJ
- Brand
- Estradiol
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Sep 2026
- FDA classified
- 28 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 8 Sep 2026 | Recall initiated by company | |
| 28 Sep 2026 | Classified by FDA | +20 days |
| 7 Oct 2026 | Published in enforcement report | +9 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; packets were found to be either empty or partially full.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Defective Container; packets were found to be either empty or partially full.
Which lots are affected?
Lot # 245226005B, Exp Date: 04/30/2028.
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 13 Oct 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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