# FDA recall D-0435-2015

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2015-03-11.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0435-2015
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-03-11
- **Report date:** 2015-04-15
- **Termination date:** 2015-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0435-2015

## Citation

> AI Analytics. FDA recall D-0435-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0435-2015. Source: US FDA. Licensed CC0.

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