RecallRadar

FDA Drug recall D-0353-2022

Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield…

On 2022-01-12 the FDA classified a Class II recall of Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield… by Perrigo, citing failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0353-2022
ClassificationClass II
Statusterminated
Initiated2021-07-27
Published2022-01-12
Last updated2026-09-13 11:52 UTC
CompanyPerrigo
DistributionUS

Product

Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2

Reason

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Identifiers

upc311917186252
code_infoLot # 0KE2447, 0KE2982, Exp 01/31/2022; 0ME2515, Exp 04/30/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0353-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.