Recalls / Class I
Class ID-0317-2024
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 Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
- Affected lot / code info
- Lot#: T08740, T08742, Exp 06/30/2026
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
- 21,900 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-0317-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.