# 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 — FDA Safety Label Change

> Defective Container; packets were found to be either empty or partially full.

**Manufacturer:** ANI Pharmaceuticals, Inc.
**Date of action:** 20260527
**Canonical URL:** https://drugsmonitor.com/recall/1bf2b5f5-3df4-4301-b211-f5c40b689930
**Last updated:** 2026-06-11

## Summary

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 (ANI Pharmaceuticals, Inc.) — Safety Label Change on 20260527.

Defective Container; packets were found to be either empty or partially full.

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*Educational recall record from DrugsMonitor.com. Confirm details with FDA primary sources.*