# FDA recall D-0816-2021

> **Morton Grove Pharmaceuticals, Inc.** · Class II · drug recall initiated 2021-09-03.

## Product

Valproic Acid Oral Solution USP,  (250 mg/5 mL),  1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16

## Reason for recall

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

## Distribution

Nationwide USA and China

## Key facts

- **Recall number:** D-0816-2021
- **Recalling firm:** Morton Grove Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2021-09-03
- **Report date:** 2021-09-29

- **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-0816-2021

## Citation

> AI Analytics. FDA recall D-0816-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0816-2021. Source: US FDA. Licensed CC0.

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