Recalls / Class I
Class ID-0316-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- a) Lot#: T10810, Exp 10/31/2025 b) Lot#: T08730, T08731, T08732, T08733, Exp 05/31/2025; T10808, Exp 09/30/2025
Why it was recalled
Microbial Contamination of Non-Sterile Products
Recalling firm
- Firm
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 184 Liberty Corner Rd, N/A, Warren, New Jersey 07059-6796
Distribution
- Quantity
- a) 31,632 bottles; b) 336,528 bottles
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2023-12-26
- FDA classified
- 2024-02-07
- Posted by FDA
- 2024-01-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0316-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.