Quick Facts at a Glance
- Recall Date
- May 12, 2026
- Hazard Level
- HIGH
- Brands
- ESTRADIOL, ANI Pharmaceuticals, Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ESTRADIOL, ANI Pharmaceuticals, Inc.
- Model numbers
- Lot M251109, exp Nov 2027
- UPC codes
- 70954-530, 70954-531, 70954-532, 70954-533, 70954-534, 70954-531-10, 70954-531-20, 70954-532-10 +7 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 12, 2026
Reported by FDA DRUG
May 27, 2026
RecallRadar source check
June 3, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Defective Container; packets were found to be either empty or partially full.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact ANI Pharmaceuticals, Inc. or your healthcare provider for guidance. Notification method: Letter
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Full Description
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. Generic: ESTRADIOL; Brand: ESTRADIOL. Reason: Defective Container; packets were found to be either empty or partially full.. Classification: Class II. Quantity: 3964 Cartons. Distribution: Nationwide in the USA
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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