Estradiol Gel 0.1% Packets
ANI Pharmaceuticals is recalling Estradiol Gel 0.1% packets due to a defective container issue resulting in empty or partially full packets.
Check your medication packets to ensure they contain the expected amount of gel. If you find empty or partially full packets, contact your pharmacist or healthcare provider for a replacement and do not use the affected product.
Why it was recalled
Defective Container; packets were found to be either empty or partially full.
How to identify it
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
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-05-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification