AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg — Class II drug recall D-1875-2019
Terminated recall by AVKARE Inc., reported 2019-09-18, distributed nationwide. Failed Stability Specifications.
| Recall number | D-1875-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2019-08-28 |
| Classified | 2019-09-17 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2021-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 5,953 bottles |
| Reason classes | specification failure |
| NDC | 42291-0297-50 |
| Lot numbers | 067180011A, 067180012A, 06718027B1 |
| Expiration dates | 2021-04, 2021-09 |
Product
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Reason for recall
Failed Stability Specifications.
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-1875-2019. 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.