FDA Drug recall D-0341-2022
Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinn…
- FDA Drug
- Class II
- terminated
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinn… by Perrigo, citing failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0341-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-27 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Perrigo |
| Distribution | US |
Product
Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Identifiers
| upc | 041260355882 |
|---|---|
| code_info | lot 0LE2178, Exp 1/31/2022; 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-0341-2022%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.