Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 ...

FDA Recall #D-0316-2024 — Class I — December 26, 2023

Recall #D-0316-2024 Date: December 26, 2023 Classification: Class I Status: Ongoing

Product Description

Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Reason for Recall

Microbial Contamination of Non-Sterile Products

Recalling Firm

Haleon US Holdings LLC — Warren, NJ

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

a) 31,632 bottles; b) 336,528 bottles

Distribution

USA nationwide

Code Information

a) Lot#: T10810, Exp 10/31/2025 b) Lot#: T08730, T08731, T08732, T08733, Exp 05/31/2025; T10808, Exp 09/30/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated