FDA Drug recall D-0732-2026
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Phar…
- FDA Drug
- Class I
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class I recall of Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Phar… by Jb Chemicals And Pharmaceuticals, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0732-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-06-24 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jb Chemicals And Pharmaceuticals |
| Distribution | US |
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
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.
Identifiers
| ndc | 16571-401-10 |
|---|---|
| code_info | Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0732-2026%22
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