Estradiol Gel 0.1%
ANI Pharmaceuticals is recalling Estradiol Gel 0.1% due to defective packets that may be empty or partially full.
Check your medication packets to ensure they are properly filled. If you find an empty or partially full packet, stop using the product and contact your pharmacist or ANI Pharmaceuticals for further instructions.
Why it was recalled
ANI Pharmaceuticals is recalling Estradiol Gel 0.1% due to a defective container issue where packets may be empty or partially full. This product was distributed nationwide.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one 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
- Recall #
- D-0543-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from ANI Pharmaceuticals, Inc.
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification