Drug FDA Class III Ongoing Mislabeling

Cetirizine Hydrochloride Tablets USP 10 mg, 500 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 16571-402-50

JB Chemicals and Pharmaceuticals Ltd Published Oct 29, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact JB Chemicals and Pharmaceuticals Ltd or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Tablet/Capsules Imprinted with Wrong ID

Affected products (1)

Cetirizine Hydrochloride Tablets USP 10 mg, 500 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 16571-402-50

CETIRIZINE HYDROCHLORIDE · 13,440 bottles

NDC: 16571-402, 16571-402-10, 16571-402-30, 16571-402-50

Lot codes: PY925014

Code info: Lot # PY925014, PY925013, Exp. 1/31/2028

Affected areas

Nationwide

Timeline

Initiated

Sep 12, 2025
Published

Oct 29, 2025

Recall number: D-0033-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.