Estradiol Gel Recalled Nationwide for Defective Packet Sealing
Padagis US LLC recalls Estradiol Gel 0.1% nationwide due to defective packets that may not be fully sealed, potentially allowing ethanol loss.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a container defect that could lead to loss of ethanol from the product. While no illnesses or injuries have been reported, the potential for product degradation due to improper sealing meets the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Padagis US LLC is recalling Estradiol Gel, 0.1% (0.25 mg/g), supplied in 30-packet cartons. The affected lot is #193109 with an expiration date of 07/31/2026, and approximately 4,944 cartons were distributed nationwide in the United States.
Some packets in the affected cartons may not be fully sealed. This defect could allow loss of ethanol from the product.
Patients who received this medication should check their carton and packet lot numbers against the recalled lot. Patients should contact their healthcare provider or pharmacy if they have questions about whether their medication is affected by this recall.
The recalled product
- Product
- Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
- Manufacturer
- Padagis US LLC
- Category
- Drug
- Affected units
- 4,944
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 # 193109
- Exp. 07/31/2026
Distribution
Distributed nationwide across the United States.
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