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

Is NDC 0555-0323-02 recalled?

Hydroxyzine Pamoate · 100 CAPSULE in 1 BOTTLE (0555-0323-02)

Yes — this exact package was recalled

1 FDA recall names the code 0555-0323-02 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
Hydroxyzine Pamoate
Strength
HYDROXYZINE PAMOATE 25 mg/1
Form
Capsule · Oral
Labeler
Teva Pharmaceuticals USA, Inc.
Type
Human Prescription Drug
Product code
0555-0323

Recalls naming this package

Class II · Moderate risk

Teva Hydroxyzine Pamoate Capsules

CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

Terminated Unapproved drug Teva Pharmaceuticals USA NDC 0555-0323-02 D-1095-2014

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

  • 0555-0972 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 4
  • 0555-9123 Jolessa 3
  • 0555-0324 Hydroxyzine Pamoate 2
  • 0555-0777 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2
  • 0555-0808 See recall 2
  • 0555-0899 Estradiol 2