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

Is NDC 0093-5416-01 recalled?

Clozapine · 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5416-01)

Yes — this exact package was recalled

1 FDA recall names the code 0093-5416-01 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
Clozapine
Strength
CLOZAPINE 12.5 mg/1
Form
Tablet, Orally Disintegrating · Oral
Labeler
Teva Pharmaceuticals USA, Inc.
Type
Human Prescription Drug
Product code
0093-5416

Recalls naming this package

Class II ยท Moderate risk

Clozapine Orally Disintegrating Tablets

Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.

Terminated Failed specification Teva Pharmaceuticals USA NDC 0093-5416-01 D-0001-2019

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