Fexofenadine HCl Tablets — Class II drug recall D-0428-2019
Terminated recall by Mylan Pharmaceuticals Inc., reported 2019-02-06, distributed nationwide. Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testi
| Recall number | D-0428-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2019-01-18 |
| Classified | 2019-02-04 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2019-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 88,090 bottles |
| Reason classes | specification failure |
| NDC | 00378-0782-05, 00378-0782-93 |
Product
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
Reason for recall
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
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-0428-2019. 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.