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Drug FDA Class II Ongoing Quality

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. Published May 27, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact ANI Pharmaceuticals, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

ESTRADIOL · 3964 Cartons

NDC: 70954-530, 70954-531, 70954-532, 70954-533, 70954-534, 70954-531-10, 70954-531-20, 70954-532-10, 70954-532-20, 70954-533-10, 70954-533-20, 70954-534-10, 70954-534-20, 70954-530-10, 70954-530-20
Lot codes: M251109
Code info: Lot M251109, exp Nov 2027

Affected areas

Nationwide

Timeline

  1. Initiated
    May 12, 2026
  2. Published
    May 27, 2026
Recall number
D-0543-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.