FDA Drug recall D-0435-2015
Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a)…
- FDA Drug
- Class III
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class III recall of Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a)… by Mylan Pharmaceuticals, citing failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0435-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-03-11 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA.
Reason
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Identifiers
| code_info | Lot #: 3047303, Exp 04/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0435-2015%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.