Estradiol Gel Packets Recalled for Empty or Partially Full Containers
ANI Pharmaceuticals is recalling Estradiol Gel 0.1% (Lot M251109) distributed nationwide because some packets were found to be either empty or partially full.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a packaging/container defect (empty or partially full packets) that poses a risk of underdosing or non-administration of a prescription medication, but no adverse health consequences have been reported.
Plain-English summary
ANI Pharmaceuticals, Inc. is recalling Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet due to defective containers. Approximately 3,964 cartons (Lot M251109, expiration November 2027) were distributed nationwide in the USA. Packets were found to be either empty or partially full.
Consumers who have received affected cartons should stop using the product and contact ANI Pharmaceuticals or their healthcare provider for guidance. Patients should not discontinue estradiol therapy without consulting their physician, as this is a prescription medication.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL)
- Brand
- ESTRADIOL
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Hazard
- defective-container
- underfilled-dose
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot M251109
- exp Nov 2027
UPCs (5)
- 0370954531104
- 0370954530107
- 0370954532101
- 0370954534105
- 0370954533108
Distribution
Distributed nationwide across the United States.