Cetirizine Hydrochloride Tablets Recalled for Incorrect Tablet Imprinting
Cetirizine Hydrochloride tablets distributed nationwide are being recalled due to incorrect imprinting. Consumers should stop using the product and contact their pharmacist or physician.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Incorrect tablet imprinting is a minor labeling error. FDA Class III classification supports a Moderate (2) severity per the rubric.
Plain-English summary
Cetirizine Hydrochloride 10 mg tablets manufactured by JB Chemicals and Pharmaceuticals Ltd and distributed by Rising Pharma Holdings, Inc. are being recalled. The tablets are imprinted with incorrect identification.
Approximately 9,936 bottles with lot number PY925014A (expiration January 31, 2028) have been distributed nationwide under NDC 16571-402-10.
Consumers who have this product should discontinue use and contact their pharmacist or healthcare provider for instructions on what to do.
The recalled product
- Product
- CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE)
- Brand
- CETIRIZINE HYDROCHLORIDE
- Manufacturer
- JB Chemicals and Pharmaceuticals Ltd
- Category
- Drug
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # PY925014A
- Exp. 1/31/2028
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CETIRIZINE HYDROCHLORIDE
- ModerateCetirizine Hydrochloride Tablets Recalled for Incorrect Imprint
FDA (Drugs) · 2025-10-29
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27