CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity Specifications
Perrigo Company is recalling CVS Allergy Relief Fexofenadine Hydrochloride 180 mg tablets due to an out-of-specification impurity result found during stability testing. The recall affects one lot distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths. The hazard is a quality specification failure detected during routine testing with no evidence of actual harm to consumers, making this a precautionary recall.
Plain-English summary
Perrigo Company PLC is recalling CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 24-hour antihistamine, in 30-count bottles due to failed impurities and degradation specifications. During stability testing, Lot #1DV1855 (expiration 4/1/2022) was found to have an out-of-specification result for an identified impurity.
The affected product was distributed nationwide in the United States. Consumers who have purchased this product should stop using it and consult with their pharmacist or healthcare provider regarding their options.
No illnesses or injuries have been reported in connection with this recall. The product is identified as NDC 69842-698-39 and UPC 0 50428 62564 4.
The recalled product
- Product
- CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Antihistamine Tablets
- Affected units
- 2,784
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 # 1DV1855
- exp 4/1/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Perrigo Company PLC 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.
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