Teva Recalls Fluoxetine Capsules Due to Residual Solvent Impurity
Teva Pharmaceuticals USA is recalling specific lots of Fluoxetine Capsules 10 mg due to an elevated level of a residual solvent impurity in the active ingredient.
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 FDA classified this as a Class II recall. The hazard involves a chemical impurity exceeding toxicological thresholds, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported immediate serious injury.
Plain-English summary
Teva Pharmaceuticals USA is recalling Fluoxetine Capsules USP, 10 mg, in 100-count bottles. The affected product is prescription-only and was manufactured by Pliva Krakow Pharmaceutical Company S.A. in Krakow, Poland, for Teva Pharmaceuticals USA in Sellersville, PA. The specific lot number is 6A207012, with an expiration date of 7/2015. The product was distributed nationwide.
The recall was initiated because the product contains an elevated level of a residual solvent impurity in the active pharmaceutical ingredient (API). This level exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be discontinued and returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- FLUOXETINE (FLUOXETINE)
- Brand
- FLUOXETINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
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 #: 6A207012
- Exp 7/2015.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA 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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