FDA-Drug2026-05-27Class IIPACKAGING DEFECT
ANI Pharmaceuticals estradiol gel recalled for defective packets
Nationwide distributionDrugs
What this means
ANI Pharmaceuticals is recalling estradiol gel (0.1%, 0.25 mg packets) because some packets in affected cartons were found to be empty or only partially filled. This could mean patients receive less medication than prescribed. The recall affects carton lot M251109, which expires in November 2027.
- Check your estradiol gel packets to see if any are empty or partially full.
- Contact your pharmacy or doctor if you have questions about whether your medication is affected.
- Do not use packets that appear empty or underfilled; ask your pharmacy for a replacement.
The agency's original wording
Hazard
Defective Container; packets were found to be either empty or partially full.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
3964 Cartons
Manufactured in
210 W Main St, Baudette, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0543-2026More ANI Pharmaceuticals recalls
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