# FDA recall D-0317-2024

> **Haleon US Holdings LLC** · Class I · drug recall initiated 2023-12-26.

## Product

Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

## Reason for recall

Microbial Contamination of Non-Sterile Products

## Distribution

USA nationwide

## Key facts

- **Recall number:** D-0317-2024
- **Recalling firm:** Haleon US Holdings LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-12-26
- **Report date:** 2024-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0317-2024

## Citation

> AI Analytics. FDA recall D-0317-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0317-2024. Source: US FDA. Licensed CC0.

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