FDA Recall D-0317-2024

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

Lot / code: Lot#: T08740, T08742, Exp 06/30/2026

Quantity: 21,900 bottles

Reason for recall

Microbial Contamination of Non-Sterile Products

Recall record

Recall number: D-0317-2024
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.

‹ All recalls