Femtrace Tablets Recalled for Moisture Ingress and Impurity Failures
Warner Chilcott is recalling 5,439 bottles of Femtrace 0.9 mg tablets nationwide due to moisture ingress causing failed impurity specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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 agency classified this as an FDA Class III recall, which indicates the product is not likely to cause adverse health consequences. The hazard involves failed specifications due to moisture ingress, which is a quality control issue rather than a direct, immediate physical danger like a fire or choking hazard.
Plain-English summary
Warner Chilcott Company LLC is recalling 5,439 bottles of Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets. The product was manufactured by Pharmaceutics International Inc. for Warner Chilcott Company LLC and distributed nationwide in the United States.
The recall was initiated because individual bottles experienced moisture ingress, which resulted in the product failing impurity and degradation specifications. The affected product is identified by the code 0.9 mg: 512348A.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
- Manufacturer
- Warner Chilcott Company LLC
- Category
- Drug — Prescription Medication
- Affected units
- 5,439
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)
- 0.9 mg: 512348A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Warner Chilcott Company LLC 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.
See all 2 products in this recall →Related recalls
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