Fexofenadine Hydrochloride Tablets — Class III drug recall D-1083-2015
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2015-05-27, distributed nationwide. Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specifi
| Recall number | D-1083-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL, United States |
| Recall initiated | 2015-03-26 |
| Classified | 2015-05-15 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2015-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 1,363 ud |
| Reason classes | specification failure |
| NDC | 51079-0547-20 |
| Lot numbers | 3051728, 3053762 |
| Expiration dates | 2015-04 |
Product
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
Reason for recall
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
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-1083-2015. 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.