drugs MODERATE Updated 2026-05-27

ANI Pharmaceuticals, Inc. recalls Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot M251109, exp Nov 2027

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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View official government recall