FDA Drug recall D-0033-2026
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals &…
- FDA Drug
- Class III
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class III recall of Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals &… by Jb Chemicals And Pharmaceuticals, citing tablet/Capsules Imprinted with Wrong ID.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0033-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-09-12 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jb Chemicals And Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Tablet/Capsules Imprinted with Wrong ID
Identifiers
| ndc | 16571-402-10 |
|---|---|
| ndc | 16571-402-30 |
| ndc | 16571-402-50 |
| code_info | Lot # PY925014, PY925013, Exp. 1/31/2028 |
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-0033-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.