Rite Aid Allergy Relief Fexofenadine Tablets Recalled for Impurity
Rite Aid Allergy Relief Fexofenadine Hydrochloride 60mg tablets are being recalled due to failed impurity specifications detected during stability testing. The affected product was 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: This is an FDA Class II recall involving an out-of-specification impurity detected during stability testing. No illnesses or injuries have been reported in the source text, and the hazard is quality-control related rather than an acute safety threat, supporting a Moderate severity score.
Plain-English summary
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg antihistamine in 24-count bottles are being recalled nationwide. The manufacturer, Perrigo Company PLC, identified an out-of-specification result for impurity A during stability testing.
The recalled lot numbers are 0JE2487 (expiration 01/31/2022) and 0ME2515 (expiration 04/30/2022), manufactured in the Czech Republic and distributed by Rite Aid from their Camp Hill, Pennsylvania location. Approximately 79,776 containers were affected.
Consumers who have purchased this product should stop using it. If you have questions or concerns about this recall, contact Rite Aid or consult your healthcare provider.
The recalled product
- Product
- Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8
- Manufacturer
- Perrigo Company PLC
- Affected units
- 79,776
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 (4)
- Lot # 0JE2487
- EXP 01/31/2022
- 0ME2515
- Exp 04/30/2022
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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