Teva Recalls Fluoxetine Capsules Due to Chemical Contamination and Odor
Teva Pharmaceuticals is recalling Fluoxetine Capsules due to a customer complaint trend regarding capsule odor, indicating chemical contamination.
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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is identified as chemical contamination based on odor complaints, without reported serious injuries or fatalities.
Plain-English summary
Teva Pharmaceuticals USA is recalling Fluoxetine Capsules USP, 20 mg, in 100, 500, 1000, and 2000-count bottles. The recall is due to a customer complaint trend regarding capsule odor, which indicates chemical contamination.
The affected product is manufactured in Poland by Pliva Krakow Pharmaceutical Company S.A. and distributed nationwide and in Puerto Rico. The recall covers 257,904 bottles across multiple lot numbers with expiration dates ranging from September 2015 to December 2015.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The specific lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- FLUOXETINE (FLUOXETINE)
- Brand
- FLUOXETINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Affected units
- 257,904
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 (20)
- Lot #: a) 6A211150
- 6A211151
- 6A211152
- 6A211153
- 6A211154
- Exp 11/15
- 6A212083
- 6A212084
- 6A212085
- 6A212086
- Exp 12/15
- b) 6A211143
- 6A211145
- 6A211146
- 6A211147
- c) 6A209116
- 6A209117
- 6A209118
- 6A209119
- 6A209120
Distribution
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.
See all 2 products in this recall →Related recalls
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