FDA Drug recall D-0186-2024
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017
- FDA Drug
- Class II
- terminated
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017 by Cardinal Healthcare, citing CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0186-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Healthcare |
| Distribution | US |
Product
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Identifiers
| code_info | Batch P125514 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0186-2024%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.