Estradiol 0.5mg Tablets Recalled Nationwide for Storage Temperature Deviation
Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.
What this means for you
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: FDA Class II recall of a prescription hormone medication due to temperature exposure during storage that may compromise medication efficacy and stability. Classified as high because this is a risk-of-harm product where efficacy loss could affect patient health, though no illnesses or injuries have been reported.
Plain-English summary
Cardinal Healthcare is recalling Estradiol tablets USP 0.5mg (NDC 0555-0899-02, Batch 100023687) manufactured by Teva Pharmaceuticals USA, Inc. The recall affects nationwide distribution.
The recall was initiated due to Good Manufacturing Practice (CGMP) deviations during storage. The product batch was exposed to temperatures outside the manufacturer's labeled storage conditions. This temperature exposure may affect the medication's stability and potency.
Patients taking Estradiol should contact their pharmacy to determine if their medication is from the recalled batch (100023687) and discuss next steps with their healthcare provider.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL)
- Brand
- ESTRADIOL
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Hormone Replacement
- Affected units
- 1
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 (1)
- Batch 100023687
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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