Amneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
Amneal Pharmaceuticals is recalling 2,592 cartons of Estradiol Gel 0.1% because some packets were found to be 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: The recall is classified as FDA Class II, and the hazard involves packaging defects (empty or partially full packets) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Amneal Pharmaceuticals, LLC is recalling 2,592 cartons of Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton. The specific lot number is 245226005B, with an expiration date of 04/30/2028. The product is distributed nationwide in the USA.
The recall was initiated because defective containers were identified, with packets found to be either empty or partially full. This issue affects the integrity of the product packaging and dosage delivery.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL TRANSDERMAL)
- Brand
- ESTRADIOL
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Prescription Drug
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 # 245226005B
- Exp Date: 04/30/2028.
Distribution
Distributed nationwide across the United States.
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