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Class I: serious health riskOngoing

Haleon US Holdings Robitussin Honey CF Max Nighttime Adult Recall

Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg…

Haleon US Holdings LLC · Warren, NJ

Risk level
Class I
Reported by FDA
Jan 31, 2024
Recall ID
D-0317-2024
Check your lot numberHow we source this data

Summary

Haleon US Holdings recalled Robitussin Honey CF Max Nighttime Adult starting Dec 26, 2023. The FDA classified it as Class I (serious health risk) and published enforcement report D-0317-2024 on Jan 31, 2024. Reason: Microbial Contamination of Non-Sterile Products. Status: Ongoing.

Why it was recalled

Microbial Contamination of Non-Sterile Products

Product description

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

Lot numbers, UPCs & expiration codes

Lot#: T08740, T08742, Exp 06/30/2026

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-0317-2024
Classification
Class I
Status
Ongoing
Recall initiated
Dec 26, 2023
FDA report date
Jan 31, 2024
Quantity
21,900 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Haleon US Holdings LLC

Original FDA data

Every field from FDA enforcement report D-0317-2024, 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
Lot#: T08740, T08742, Exp 06/30/2026
Postal code
07059-6796
Report date
Jan 31, 2024
Product type
Drugs
Recall number
D-0317-2024
Classification
Class I
Recalling firm
Haleon US Holdings LLC
Product quantity
21,900 bottles
Reason for recall
Microbial Contamination of Non-Sterile Products
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
USA nationwide
Recall initiation date
Dec 26, 2023
Initial firm notification
Letter
Center classification date
Feb 7, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0317-2024, published Jan 31, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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