Cetirizine tablets recalled because tablets were imprinted with the wrong identifier
JB Chemicals is recalling 13,440 bottles of Cetirizine Hydrochloride Tablets USP 10 mg because the tablets were imprinted with the wrong identification code.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 500-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 13,440 bottles from lots PY925014 and PY925013, 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 lots 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
- 13,440
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 (3)
- Lot # PY925014
- PY925013
- 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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