FDA Drug recall D-0289-2022
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite…
- FDA Drug
- Class II
- terminated
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite… by The Harvard Drug Group, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0289-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-03 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| code_info | Lot, expiry: Lot H00005, exp 01/2022; Lot H00006, exp 04/2022; Lot H00007, exp 07/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2025-10-29 · The Harvard Drug Group
All The Harvard Drug Group recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0289-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.