FDAClass IIIOctober 29, 2025

Cetirizine Hydrochloride Tablets USP 10 mg recall

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.

Why was Cetirizine Hydrochloride Tablets USP 10 mg recalled?

Tablet/Capsules Imprinted with Wrong ID

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # PY925014A; Exp. 1/31/2028

Product
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.
Recalling firm
JB Chemicals and Pharmaceuticals Ltd
Quantity
9936 bottles
Distribution
U.S. Nationwide
Recall date
October 29, 2025
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls