Perrigo Fexofenadine Hydrochloride 180mg tablets recalled for impurity
Perrigo Company PLC is recalling Fexofenadine Hydrochloride 180mg antihistamine tablets due to an out-of-specification impurity result detected during stability testing. The recall affects approximately 89,664 containers distributed nationwide.
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 II recall involving failed impurity specifications without any reported illnesses or injuries. The source text indicates a quality control failure detected through testing rather than a harm event, making this a precautionary recall that meets the Moderate severity threshold.
Plain-English summary
Perrigo Company PLC is recalling Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine in 100-count bottles (NDC 45802-571-78, UPC 3 45802 571 78 6) due to failed impurities and degradation specifications. During stability testing, an out-of-specification result was obtained for impurity A.
The affected product was made in the Czech Republic and distributed by Perrigo in Allergan, Michigan. Approximately 89,664 containers have been distributed nationwide in the USA across multiple lots: Lot 0FR0563 (Exp 02/28/22), 0GR0530 (Exp 03/31/22), and lots 0KR0434, 0KR0435, 0LR0366, 0LR0367, and 0LR0368 (Exp 06/30/22).
Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist about alternative treatment options.
The recalled product
- Product
- Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Antihistamine Tablet
- Affected units
- 89,664
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 (10)
- Lot 0FR0563
- Exp 02/28/22
- 0GR0530
- Exp 03/31/22
- 0KR0434
- 0KR0435
- 0LR0366
- 0LR0367
- 0LR0368
- 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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