Robitussin Honey CF Max Nighttime Adult Recalled for Microbial Contamination
Haleon US Holdings LLC is recalling Robitussin Honey CF Max Nighttime Adult cough medicine due to microbial contamination. The FDA Class I recall affects 21,900 bottles distributed nationwide.
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 classification requires a minimum severity score of 4 per the rubric. No illnesses or deaths are reported in the source, preventing a Critical rating. Microbial contamination of drug products represents a serious health hazard warranting immediate recall.
Plain-English summary
Haleon US Holdings LLC is recalling Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25 mg), 8 fluid ounce bottles. The FDA has classified this as a Class I recall due to microbial contamination of the product.
The affected product includes bottles bearing lot numbers T08740 and T08742, with an expiration date of June 30, 2026. Approximately 21,900 bottles were distributed nationwide by GSK Consumer Healthcare, located in Warren, New Jersey.
Consumers who have this product should stop using it. Those with health concerns should contact a healthcare provider.
The recalled product
- 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
- Manufacturer
- Haleon US Holdings LLC
- Category
- Drug — OTC Cough Medicine
- Hazard
- Affected units
- 21,900
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 (3)
- Lot#: T08740
- T08742
- Exp 06/30/2026
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.
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