# FDA recall D-0470-2022

> **Ultra Seal Corporation** · Class II · drug recall initiated 2022-01-24.

## Product

Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50

## Reason for recall

cGMP deviations

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0470-2022
- **Recalling firm:** Ultra Seal Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-24
- **Report date:** 2022-02-09
- **Termination date:** 2023-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Paltz, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0470-2022

## Citation

> AI Analytics. FDA recall D-0470-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0470-2022. Source: US FDA. Licensed CC0.

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