TopCare Allergy Relief — Class II drug recall D-0350-2022
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-0350-2022 |
|---|---|
| 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 | 13,656 containers |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00036800332775, 00036800332782, 00036800332805, 00036800332829 |
| NDC | 36800-0319-13, 36800-0319-22, 36800-0319-75, 36800-0319-95 |
| Expiration dates | 2021-12-31, 2022-02-28, 2022-03-31 |
Product
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the 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-0350-2022. 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.