Multi event Drug Recall Enforcement Report Class III voluntary initiated by JB Chemicals and Pharmaceuticals Ltd, originally initiated on 09-12-2025 for the product 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. The product was recalled due to tablet/capsules imprinted with wrong id. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0032-2026 | 09-12-2025 | 10-29-2025 | Class III | 9936 bottles | 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. | Tablet/Capsules Imprinted with Wrong ID | Ongoing |
| D-0033-2026 | 09-12-2025 | 10-29-2025 | Class III | 13,440 bottles | 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 | Tablet/Capsules Imprinted with Wrong ID | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 16571-402 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Tablet | Oral | Rising Pharma Holdings, Inc. | Human Otc Drug |
