← FDA ENFORCEMENT
D-0316-2024Class I

Haleon US Holdings LLC

Recalling firm
Haleon US Holdings LLC
Product type
Drug
Status
Ongoing
Report date
2024-01-31
Distribution
USA nationwide
Firm state
NJ
Product quantity
a) 31,632 bottles; b) 336,528 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.