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.
Recall at a glance
- Quantity recalled
- 3964 Cartons
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%
- Lot code
- M251109, 2027
- Strength
- 0.25 mg
- NDC / UPC
- NDC 70954-531-20
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from ANI Pharmaceuticals, Inc.
Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification