Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Fluoxetine Capsules USP Recalled by Teva Pharmaceuticals USA Due to Chemical Contamination: Recall due to a customer complaint...

Date: February 12, 2014
Company: Teva Pharmaceuticals USA
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Teva Pharmaceuticals USA directly.

Affected Products

Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.

Quantity: 72,356 bottles

Why Was This Recalled?

Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teva Pharmaceuticals USA

Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report