RecallRadar

FDA Drug recall D-0339-2022

H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San A…

On 2022-01-12 the FDA classified a Class II recall of H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San A… 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-0339-2022
ClassificationClass II
Statusterminated
Initiated2021-07-27
Published2022-01-12
Last updated2026-09-13 11:52 UTC
CompanyPerrigo
DistributionUS

Product

H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9

Reason

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

Identifiers

upc041220530809
code_infoLot 0JE2491, 0LE2178, Exp 01/31/2022; 0ME2516, Exp 4/30/2022

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-0339-2022%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.