Haleon US Holdings LLC: Drug Recall

Recall #D-0316-2024 · 12/26/2023

Class I: Dangerous

Recall Details

Recall Number: D-0316-2024
Classification: Class I
Product Type: Drug
Recalling Firm: Haleon US Holdings LLC
Status: Ongoing
Date Initiated: 12/26/2023
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 31,632 bottles; b) 336,528 bottles

Reason for Recall

Microbial Contamination of Non-Sterile Products

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

Distribution Pattern

USA nationwide

Other Recalls by Haleon US Holdings LLC

Class III: Low Risk 12/26/2025

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Class III: Low Risk 08/05/2025

Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Class I: Dangerous 12/26/2023

Microbial Contamination of Non-Sterile Products

View all recalls by Haleon US Holdings LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.