FDA Recall D-0316-2024

Haleon US Holdings LLC · Warren, NJ

Class I — life-threatening Ongoing 870 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

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

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

Reason for recall

Microbial Contamination of Non-Sterile Products

Recall record

Recall number: D-0316-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA nationwide
Recall initiated: 2023-12-26
Classified by FDA Center: 2024-02-07
FDA published: 2024-01-31
Recalling firm: Haleon US Holdings LLC
Firm location: Warren, NJ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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