TopCare Allergy Relief (Perrigo) – Impurity Specifications (2021)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
Brand
Perrigo Company PLC
Lot Codes / Batch Numbers
Lot # 0LE2178, Exp 01/31/2022
Products Sold
Lot # 0LE2178, Exp 01/31/2022
Perrigo Company PLC is recalling TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottl due to Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026