FDA Drugs recall ·
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton… recall
- Recall number
- D-0543-2026
- Date
- (initiated May 12, 2026)
- Company / brand
- ANI Pharmaceuticals, Inc.
210 W Main St, Baudette, MN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3964 Cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Defective Container; packets were found to be either empty or partially full.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot M251109, exp Nov 2027
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0543-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.