Why it was recalled
Microbial Contamination of Non-Sterile Products
Product description
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
Lot numbers, UPCs & expiration codes
a) Lot#: T10810, Exp 10/31/2025 b) Lot#: T08730, T08731, T08732, T08733, Exp 05/31/2025; T10808, Exp 09/30/2025
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0316-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 26, 2023
- FDA report date
- Jan 31, 2024
- Quantity
- a) 31,632 bottles; b) 336,528 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Haleon US Holdings LLC
Original FDA data
Every field from FDA enforcement report D-0316-2024, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93702
- Address
- 184 Liberty Corner Rd
- Code information
- a) Lot#: T10810, Exp 10/31/2025 b) Lot#: T08730, T08731, T08732, T08733, Exp 05/31/2025; T10808, Exp 09/30/2025
- Postal code
- 07059-6796
- Report date
- Jan 31, 2024
- Product type
- Drugs
- Recall number
- D-0316-2024
- Classification
- Class I
- Recalling firm
- Haleon US Holdings LLC
- Product quantity
- a) 31,632 bottles; b) 336,528 bottles
- Reason for recall
- Microbial Contamination of Non-Sterile Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA nationwide
- Recall initiation date
- Dec 26, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 7, 2024