Cetirizine hundred count bottles recalled over tablets imprinted with wrong identifier
JB Chemicals is recalling 9,936 hundred-count bottles of Cetirizine Hydrochloride Tablets USP 10 mg because the tablets were imprinted with the wrong identification code.
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: Scored 2 as an FDA Class III labelling error, which the rubric places at 1 or 2; the imprint is wrong but the record describes no defect in the medicine itself.
Plain-English summary
Cetirizine Hydrochloride Tablets USP 10 mg, in 100-tablet bottles, manufactured by Unique Pharmaceuticals Labs in Mumbai, India and distributed by Rising Pharma Holdings, are being recalled because the tablets are imprinted with the wrong ID.
The recall covers 9,936 bottles from lot PY925014A, expiring 31 January 2028. The product was distributed nationwide in the United States. The FDA has classified the recall as Class III.
A tablet imprint is what allows a pharmacist or patient to identify a loose tablet, so an incorrect imprint could cause the tablet to be identified as a different medicine. The enforcement record reports no injuries.
Anyone holding a bottle from the listed lot should contact their pharmacy about a replacement.
The recalled product
- Product
- CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE)
- Brand
- CETIRIZINE HYDROCHLORIDE
- Manufacturer
- JB Chemicals and Pharmaceuticals Ltd
- Category
- Drug — Antihistamine
- Affected units
- 9,936
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.
Part of a larger recall action
This product is one of 2 recalled by JB Chemicals and Pharmaceuticals Ltd under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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