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

Is NDC 16571-0401-10 recalled?

Cetirizine Hydrochloride · 100 TABLET in 1 BOTTLE (16571-401-10)

Yes — this exact package was recalled

1 FDA recall names the code 16571-0401-10 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.

1 of these recalls is still ongoing.

Active ingredient
Cetirizine Hydrochloride
Strength
CETIRIZINE HYDROCHLORIDE 5 mg/1
Form
Tablet · Oral
Labeler
Rising Pharma Holdings, Inc.
Type
Human OTC Drug
Product code
16571-0401

Recalls naming this package

Class I · High risk

Cetirizine Hydrochloride Tablets USP 5 mg

Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.

Ongoing Cross-contamination JB Chemicals and Pharmaceuticals Ltd NDC 16571-401-10 D-0732-2026

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