Fexofenadine Hydrochloride Tablets — Class II drug recall D-0289-2022
Terminated recall by The Harvard Drug Group, reported 2021-12-29, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0289-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2021-08-03 |
| Classified | 2021-12-21 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2023-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 2,239 bottles |
| Reason classes | specification failure |
| NDC | 00904-6979-40 |
| Lot numbers | H00005, H00006, H00007 |
| Expiration dates | 2022-01, 2022-04, 2022-07 |
Product
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
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-0289-2022. 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.