Fexofenadine HCL Tablets USP — Class II drug recall D-1871-2019
Terminated recall by Aurolife Pharma, LLC, reported 2019-09-25, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-1871-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurolife Pharma, LLC, Dayton, NJ, United States |
| Recall initiated | 2019-08-23 |
| Classified | 2019-09-17 |
| Reported by FDA | 2019-09-25 |
| Terminated | 2022-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 6,104 bottles |
| Reason classes | specification failure |
| Lot numbers | 04/21, 067180012A, 06718027B1, 09/21 |
Product
Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.
Reason for recall
Failed Impurities/Degradation 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-1871-2019. 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.