CLASS I Drug recall · Reported 31 Jan 2024 · FDA Enforcement Report
Robitussin Honey CF Max Nighttime Adult recalled by Haleon US Holdings
Haleon US Holdings is recalling Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), distributed nationwide in the US. The recall was initiated on 26 Dec 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0317-2024
- FDA event ID
- 93702
- Recalling firm
- Haleon US Holdings, Warren, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 26 Dec 2023
- FDA classified
- 7 Feb 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 26 Dec 2023 | Recall initiated by company | |
| 31 Jan 2024 | Published in enforcement report | +36 days |
| 7 Feb 2024 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
USA nationwide
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products
Which lots are affected?
Lot#: T08740, T08742, Exp 06/30/2026
Where was it sold?
USA nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 16 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93702| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Robitussin Honey CF Max Non-Drowsy Adult recalled by Haleon US Holdings | Haleon US Holdings | Sterility | Nationwide |
More recalls from Haleon US Holdings
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Gas-X Extra Strength, Simethicone 125 mg/Antigas recalled | Haleon US Holdings | Packaging Defects | Nationwide |
| Drug | CLASS II | Gas-X, Simethicone 125 mg/ Antigas recalled by Haleon US Holdings | Haleon US Holdings | Other | Nationwide |
| Drug | CLASS III | parodontax (cetylpyridinium chloride)Active Gum Health recalledParodontax | Haleon US Holdings | Other | Nationwide |
| Drug | CLASS III | Sensodyne Pronamel (Potassium nitrate recalled by Haleon US Holdings | Haleon US Holdings | Packaging Defects | Nationwide |
| Drug | CLASS I | Robitussin Honey CF Max Non-Drowsy Adult recalled by Haleon US Holdings | Haleon US Holdings | Sterility | Nationwide |