Notice names this product. ANI Pharmaceuticals’s Estradiol Gel is named in FDA Class II recall D-0543-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Defective Container; packets were found to be either empty or partially full. Identifying details: Lot M251109, exp Nov 2027. Units affected: 3964 Cartons. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Defective Container; packets were found to be either empty or partially full.
Company / brand: ANI Pharmaceuticals recalls
Affected product: Estradiol Gel recall status
Official ID D-0543-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.