The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0316-2024·Announced 2024-01-31

Robitussin Honey CF Max Non-Drowsy Adult recalled for microbial contamination

GSK Consumer Healthcare recalls Robitussin Honey CF Max Non-Drowsy Adult due to microbial contamination in non-sterile products distributed nationwide. Affected lot numbers carry specific expiration dates.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I drug recalls automatically qualify as a minimum score of 4 (Severe) per the rubric. This recall involves confirmed microbial contamination of a non-sterile product intended for consumption.

Plain-English summary

Robitussin Honey CF Max Non-Drowsy Adult, an over-the-counter cough and cold medication, is being recalled by the FDA. The product contains Acetaminophen 650 mg and Dextromethorphan HBr 20 mg and is available in 4 FL OZ (118 mL) and 8 FL OZ (237 mL) bottles distributed nationwide.

The FDA Class I recall was initiated due to microbial contamination of non-sterile products. The affected lots are Lot# T10810 (4 FL OZ size, expiring 10/31/2025) and Lot# T08730, T08731, T08732, T08733 (8 FL OZ size, expiring 05/31/2025), and Lot# T10808 (8 FL OZ size, expiring 09/30/2025).

Approximately 31,632 bottles of the 4 FL OZ size and 336,528 bottles of the 8 FL OZ size have been distributed. The product is manufactured by Haleon US Holdings LLC and distributed by GSK Consumer Healthcare, Warren, NJ.

Consumers who have purchased this product with the specified lot numbers should not use it. Those with questions or concerns should contact the manufacturer or their healthcare provider.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Haleon US Holdings LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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