Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 50111-0648-02 recalled?

Fluoxetine · 500 CAPSULE in 1 BOTTLE (50111-648-02)

Yes — this exact package was recalled

2 FDA recalls name the code 50111-0648-02 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Fluoxetine
Strength
FLUOXETINE HYDROCHLORIDE 20 mg/1
Form
Capsule · Oral
Labeler
Teva Pharmaceuticals USA, Inc.
Type
Human Prescription Drug
Product code
50111-0648

Recalls naming this package

Class II · Moderate risk

Fluoxetine Capsules USP

Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

Terminated Chemical / undeclared Teva Pharmaceuticals USA NDC 50111-648-02 D-0971-2015
Class II · Moderate risk

Fluoxetine Capsules USP

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

Terminated Chemical / undeclared Teva Pharmaceuticals USA NDC 50111-648-01 D-1280-2014

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler