Fexofenadine HCl Tablets — Class III drug recall D-0435-2015
Terminated recall by Mylan Pharmaceuticals Inc., reported 2015-04-15, distributed nationwide. Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradan
| Recall number | D-0435-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2015-03-11 |
| Classified | 2015-04-07 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2015-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 13,856 bottles |
| Reason classes | specification failure |
| NDC | 00378-0781-05, 00378-0781-91 |
| Lot numbers | 3047303 |
| Expiration dates | 2015-04 |
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 for recall
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
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-0435-2015. 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.