Perrigo basic+care Fexofenadine Tablets Recall—Failed Impurity Specifications
Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets (180 mg, 150-count bottles) distributed nationwide because impurity testing results exceeded specification limits during stability testing.
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 Class II. No illnesses, injuries, or adverse events are reported in the source text. The hazard is an out-of-specification impurity detected during stability testing, representing a potential quality control issue rather than an imminent safety threat with documented harm.
Plain-English summary
Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets, 180 mg, 24-hour formulation in 150-count bottles. The recall affects approximately 28,320 containers distributed nationwide in the United States. The product was made in the Czech Republic and distributed by Perrigo Allergan of Michigan.
The recall was initiated because an out-of-specification result was obtained for impurity A during stability testing, indicating that the product failed impurities and degradation specifications.
The affected lot numbers are 0GR0528 (Expiration 03/31/22), 0KR0473 (Expiration 04/30/22), and 0LR0369 (Expiration 06/30/22). The product NDC is 0113-7571-47 and UPC is 3 70030 11470 2.
Consumers who have purchased this product should stop using it and consult their healthcare provider for guidance.
The recalled product
- Product
- basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2
- Manufacturer
- Perrigo Company PLC
- Affected units
- 28,320
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 (6)
- Lot # 0GR0528
- Exp 03/31/22
- 0KR0473
- Exp 04/30/22
- 0LR0369
- Exp 06/30/22
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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