RecallReported October 7, 2026
Class II recall by Amneal Pharmaceuticals, LLC
Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2…
FDA's enforcement report of October 7, 2026 lists a Class II recall by Amneal Pharmaceuticals, LLC of Bridgewater, NJ. Product: Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2…. Status: Ongoing.
On the record
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Location
- Bridgewater, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall number
- D-0873-2026
- Product type
- Drugs
- Brand names
- ESTRADIOL
- Generic names
- ESTRADIOL TRANSDERMAL
- Recall initiated
- 2026-09-08
- Reported by FDA
- 2026-10-07
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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