Drug FDA Class III Ongoing Mislabeling
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.
JB Chemicals and Pharmaceuticals Ltd Published Oct 29, 2025
Risk level
Class IIIUnlikely 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, 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.
CETIRIZINE HYDROCHLORIDE · 9936 bottles
NDC: 16571-402, 16571-402-10, 16571-402-30, 16571-402-50
Lot codes: PY925014A
Code info: Lot # PY925014A; Exp. 1/31/2028
Affected areas
Nationwide
Timeline
- InitiatedSep 12, 2025
- PublishedOct 29, 2025
- Recall number
- D-0032-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
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.