Cetirizine Hydrochloride Tablets USP 5 mg — Class I drug recall D-0732-2026
Ongoing recall by JB Chemicals and Pharmaceuticals Ltd, reported 2026-07-29, distributed nationwide. Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots
| Recall number | D-0732-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | JB Chemicals and Pharmaceuticals Ltd, Mumbai, N/A, India |
| Recall initiated | 2026-06-24 |
| Classified | 2026-08-03 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| NDC | 16571-0401, 16571-0401-10 |
| Lot numbers | 2028-OCT, GY825029, GY825030, GY825031, GY825032 |
Product
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, 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 16571-401-10.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0732-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.