Cetirizine Hydrochloride Tablets Recalled for Incorrect Imprint
JB Chemicals and Pharmaceuticals Ltd is recalling Cetirizine Hydrochloride 10 mg tablets nationwide due to incorrect tablet imprinting. Affected lots: PY925014, PY925013, expiring 1/31/2028.
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: This is an FDA Class III recall for a labeling and imprinting error with no reported illnesses or injuries. The incorrect tablet imprint is a documentation and identification issue that does not pose a currently documented health risk, meeting the Moderate severity criteria for minor labeling errors.
Plain-English summary
Cetirizine Hydrochloride Tablets USP 10 mg are being recalled due to incorrect tablet imprinting. The affected product consists of 13,440 bottles with lot numbers PY925014 and PY925013, with expiration date 1/31/2028. The tablets were manufactured by Unique Pharmaceuticals Labs (a division of JB Chemicals & Pharmaceuticals Ltd) in Mumbai, India, and distributed by Rising Pharma Holdings, Inc. in East Brunswick, New Jersey. The product was distributed nationwide in the United States.
The tablets in these lots have been imprinted with incorrect identification markings. This imprinting issue could affect the proper identification of the medication. The FDA has classified this recall as Class III.
The recalled product
- Product
- CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE)
- Brand
- CETIRIZINE HYDROCHLORIDE
- Manufacturer
- JB Chemicals and Pharmaceuticals Ltd
- Category
- Drug — OTC / Allergy Medication
- Hazard
- mis-labeling
- wrong-imprint
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.
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