CVS Allergy Relief — Class II drug recall D-0335-2022
Terminated recall by Perrigo Company PLC, reported 2022-01-12, distributed nationwide. Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stabi
| Recall number | D-0335-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perrigo Company PLC, Allegan, MI, United States |
| Recall initiated | 2021-07-27 |
| Classified | 2022-01-05 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2022-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 138,144 containers |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00050428254141, 00050428534359 |
| NDC | 59779-0425-53, 59779-0425-62 |
| Expiration dates | 2022-01-31, 2022-04-30 |
Product
CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, Made in Czech Republic
Reason for recall
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0335-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.