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Ani Pharmaceuticals, Inc.

Check your batch

Check the batch codes below. If yours matches, return it for a refund rather than take it.

Class II

  • May cause temporary or medically reversible harm. Serious consequences are unlikely.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Check your batch Filed 2026-05-27

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

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

Check these codes: Lot M251109, exp Nov 2027

3964 Cartons · distributed nationwide in the usa Recall D-0543-2026 on FDA.gov ↗
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