# FDA recall D-0174-2021

> **Morton Grove Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-12-09.

## Product

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

## Reason for recall

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-0174-2021
- **Recalling firm:** Morton Grove Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-09
- **Report date:** 2020-12-30
- **Termination date:** 2022-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morton Grove, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2021

## Citation

> AI Analytics. FDA recall D-0174-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0174-2021. Source: US FDA. Licensed CC0.

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