Legacy Pharmaceutical Packaging Recalls Fluoxetine Capsules Due to Odor Complaints
Legacy Pharmaceutical Packaging is recalling 667,068 bottles of Fluoxetine Capsules, 20 mg, due to supplier complaints of unusual odor.
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 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 recall is classified as FDA Class II and involves a chemical contamination (unusual odor) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Legacy Pharmaceutical Packaging is recalling 667,068 bottles of Fluoxetine Capsules, USP, 20 mg, 30-count bottles. The product is distributed by Wal-Mart and manufactured by TEVA PHARMACEUTICALS USA. The recall involves lot numbers 131328 (Exp 08/15), 131634 (Exp 09/15), and 131833 (Exp 11/15).
The recall was initiated because the recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. This is classified as a chemical contamination issue.
Consumers who have purchased these specific lot numbers should stop using the product and contact their healthcare provider or pharmacist for guidance. The affected products were distributed nationwide.
The recalled product
- Product
- FLUOXETINE (FLUOXETINE)
- Brand
- FLUOXETINE
- Manufacturer
- Legacy Pharmaceutical Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 667,068
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 (6)
- Lot numbers: 131328
- Exp 08/15
- 131634
- Exp 09/15
- and 131833
- Exp 11/15
UPCs (2)
- 0368645130545
- 368645130545
Distribution
Distributed nationwide across the United States.
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