# FDA recall D-1875-2019

> **AVKARE Inc.** · Class II · drug recall initiated 2019-08-28.

## Product

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

## Reason for recall

Failed Stability Specifications.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-1875-2019
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-08-28
- **Report date:** 2019-09-18
- **Termination date:** 2021-10-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1875-2019

## Citation

> AI Analytics. FDA recall D-1875-2019. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1875-2019. Source: US FDA. Licensed CC0.

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