Mucinex Recall: Several Cold Medicine Products Have Incorrect Ingredient Labels

The makers of Mucinex have issued a recall of liquid bottles of Mucinex Fast-Max Night Time Cold & Flu; Mucinex Fast-Max Cold & Sinus; Mucinex Fast-Max Severe Congestion & Cough and Mucinex Fast-Max Cold, Flu & Sore Throat Due to Undeclared Levels of Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine.


mucinex-recall
Check labels for Lot Codes and Expiration

Parsippany, NJ, RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of MUCINEX® FAST-MAX® Night Time Cold & Flu; MUCINEX® FAST-MAX® Cold & Sinus; MUCINEX® FAST-MAX® Severe Congestion & Cough and MUCINEX® FAST-MAX® Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. This recall was due to a confirmed report from a retailer.

Consumer Contact: 1-888-943-4215

This mislabeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product ingredients which include Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine. The voluntary recall is being issued nationwide as a precautionary measure to ensure our consumers have all relevant facts and warnings for the active ingredients contained in the bottle.

Consumers could take a product with undeclared levels of Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine. Consumers would not be adequately warned of side effects which could potentially lead to health complications requiring urgent medical intervention, particularly in the case of acetaminophen use in people with liver impairment, taking three or more alcoholic drinks or when taking other medicines containing this active ingredient without consulting a doctor.

RB is notifying its distributors and customers by direct correspondence. As a precautionary measure, RB is asking consumers to responsibly dispose of any unused product in accordance with the following recommended guidance for drug disposal in your household trash:

  • Mix liquid medicines with an unpalatable substance such as kitty litter or used coffee grounds;
  • Place the mixture in a container such as a sealed plastic bag; and
  • Throw the container in your household trash. Consumers who have purchased this product can also contact the RB MUCINEX FAST-MAX recall toll free number at 1-888-943-4215 between the hours of 8:00 a.m.- 8:00 p.m eastern standard time with any questions or to speak with a representative, and should refer to our website, www.mucinex.com/recall for the accurate related drug facts information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

List of Potentially Impacted Batches

Product NameLOT NUMBERExpiry
Mucinex Fast-MAX Night Time Cold & Flu LiqMNT00047/31/2016
MNT00037/31/2016
MNT00057/31/2016
MNT00067/31/2016
MNT00077/31/2016
MNT00087/31/2016
MNT00097/31/2016
MNT00107/31/2016
MNT00127/31/2016
MNT00137/31/2016
MNT00117/31/2016
MNT001410/31/2016
MNT001510/31/2016
MNT001710/31/2016
MNT001610/31/2016
MNT001610/31/2016
AA0801/31/2017
MNT001811/30/2016
MNT001911/30/2016
MNT002012/31/2016
MNT002112/31/2016
MNT002212/31/2016
MNT002312/31/2016
MNT002412/31/2016
MNT002512/31/2016
AA03712/31/2017
AA06012/30/1940
AA0801/31/2017
AA0971/31/2017
Mucinex Fast Max Cold & Sinus LiquidMCS00207/31/2016
MCS00217/31/2016
MCS00197/31/2016
MCS00228/31/2016
MCS00238/31/2016
MCS00249/30/2016
MCS00259/30/2016
MCS00269/30/2016
MCS002711/30/2016
MCS002810/31/2016
MCS002910/31/2016
MCS003012/31/2016
MCS003112/31/2016
MCS003212/31/2016
MCS003312/31/2016
Mcinex FastMax Severe Congestion&Cough LiqMSC00498/31/2016
MSC00508/31/2016
MSC00518/31/2016
MSC00528/31/2016
MSC00538/31/2016
MSC00548/31/2016
MSC00558/31/2016
MSC00569/30/2016
MSC00579/30/2016
MSC00589/30/2016
MSC005910/31/2016
MSC006410/31/2016
MSC006610/30/2016
MSC006510/31/2016
MSC006310/31/2016
MSC006110/31/2016
MSC006210/31/2016
MSC006010/31/2016
MSC007111/30/2016
MSC007912/31/2016
MSC006711/30/2016
MSC006811/30/2016
MSC006911/30/2016
MSC007011/30/2016
MSC007111/30/2016
MSC0072TBD
MSC007311/30/2016
MSC007411/30/2016
MSC007511/30/2016
MSC007611/30/2016
MSC007712/31/2017
MSC007812/31/2016
MSC007912/31/2016
MSC008012/31/2017
MSC008212/31/2016
Mucinex Fast-Max Cold,Flu & Sore Throat LiqMCF00517/31/2016
MCF00487/31/2016
MCF00528/31/2016
MCF00538/31/2016
MCF00548/31/2016
MCF00558/1/2016
MCF00568/31/2016
MCF00578/31/2016
MCF00588/31/2016
MCF005910/1/2016
MCF00608/31/2016
MCF00618/31/2016
MCF00628/31/2016
MCF00639/30/2016
MCF00649/30/2016
MCF00659/30/2016
MCF00669/30/2016
MCF00679/30/2016
MCF00689/30/2016
MCF007010/31/2016
MCF006910/1/2016
MCF007110/31/2016
MCF007210/31/2016
MCF007310/31/2016
MCF007410/31/2016
MCF007510/31/2016
MCF007610/31/2016
MCF007710/31/2016
MDM004411/30/2016
MUCINEX FAST-MAX  Liquid combination – Day Night Severe Cold and Night-Time Cold & Flu.3O007268658/20/2015
WO007268646/30/2016
WO007379791/31/2017
WO007404051/31/2017
WO007065717/31/2016
WO007074427/31/2016
WO007074437/31/2016
WO007074447/31/2016
WO007078227/31/2016
WO007099537/31/2016
WO007099556/30/2016
WO007207807/31/2016
WO007210527/31/2016
WO007211707/31/2016
WO007211717/31/2016
MUCINEX FAST-MAX  Liquid combination packs – Daytime Severe Congestion & Cough Nighttime Cold& FluWO007211749/30/2016
WO0072117710/31/2016
WO0072686010/31/2016
WO007268626/30/2016
WO007269528/31/2016
WO007288616/30/2016
WO007288787/31/2016
WO007288799/30/2016
WO007078255/31/2016
WO007132267/31/2016
WO007153106/30/2016
WO007155057/31/2016

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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