The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1281-2014·Announced 2014-05-07

Teva Recalls Fluoxetine Capsules Due to Chemical Contamination and Odor

Teva Pharmaceuticals USA is recalling 72,356 bottles of Fluoxetine Capsules, 10 mg, due to a customer complaint trend regarding capsule 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, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is based on a complaint trend regarding odor rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Teva Pharmaceuticals USA is recalling 72,356 bottles of Fluoxetine Capsules USP, 10 mg, 100-count bottles. The product is prescription-only and was manufactured in Poland by Pliva Krakow Pharmaceutical Company S.A. for Teva Pharmaceuticals USA. The affected lots are 6A211158, 6A211159, and 6A211163, with an expiration date of 11/15.

The recall was initiated due to a customer complaint trend regarding capsule odor, which the FDA classifies as a chemical contamination issue. The agency has classified this recall as Class II, indicating a situation in which there is a reasonable probability that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
FLUOXETINE (FLUOXETINE)
Brand
FLUOXETINE
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
72,356

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 (4)

  • Lot #: 6A211158
  • 6A211159
  • 6A211163
  • Exp 11/15

UPCs (1)

  • 350111647015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

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