Cetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
JB Chemicals and Pharmaceuticals Ltd is recalling 34,020 bottles of Cetirizine Hydrochloride Tablets USP 5 mg because some tablets were found to contain Ranitidine due to cross contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I. Under the rubric, an FDA Class I recall is scored 5 (Critical).
Plain-English summary
JB Chemicals and Pharmaceuticals Ltd is recalling 34,020 100-count bottles of Cetirizine Hydrochloride Tablets USP 5 mg (NDC 16571-401-10). The affected lots are GY825029, GY825030, GY825031, and GY825032, with expiration date 2028-OCT. The product was distributed nationwide in the USA by Rising Pharma Holdings, Inc.
The recall was initiated after customer complaints about discolored tablets and red dots on the tablets. Testing determined that the discoloration was caused by cross contamination with Ranitidine, another drug product. The FDA has classified this recall as Class I.
Consumers who have a bottle matching the recalled lot numbers and expiration date should verify whether their product is included in the recall and follow the instructions in the FDA recall notice. The recall notice does not describe a specific return or refund process; consumers with questions may contact their pharmacist or healthcare provider.
The recalled product
- Product
- CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE)
- Brand
- CETIRIZINE HYDROCHLORIDE
- Manufacturer
- JB Chemicals and Pharmaceuticals Ltd
- Category
- Drug — OTC Antihistamine Tablets
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 (5)
- Lots: GY825029
- GY825030
- GY825031
- GY825032
- expires: 2028-OCT
Distribution
Distributed nationwide across the United States.
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