EQUALINE aller-ease fexofenadine hydrochloride tablets — Class II drug recall D-0328-2022
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-0328-2022 |
|---|---|
| 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 | 55,032 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00041163480674, 00041163498471 |
| NDC | 41163-0571-01, 41163-0571-22 |
| Expiration dates | 2021-12-31, 2022-02-28 |
Product
EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
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-0328-2022. 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.