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Mucinex Fast-Max Severe Congestion & Cough FDA Alerts

The FDA Alert(s) below may be specifically about Mucinex Fast-Max Severe Congestion & Cough or relate to a group or class of drugs which include Mucinex Fast-Max Severe Congestion & Cough (dextromethorphan/guaifenesin/phenylephrine).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for dextromethorphan/guaifenesin/phenylephrine

FDA Advises Consumers Not to Use Rompe Pecho Cough Syrup

Oct 11, 2019

Audience: Consumers

October 11, 2019 -- FDA advises consumers not to use Rompe Pecho EX and Rompe Pecho CF cough syrups distributed by Efficient Laboratories, Inc., Miami, Florida, due to microbial contamination risks. These are over-the-counter medicines for children six years and older. FDA recommends consumers stop using these medicines and dispose of them. These contaminated cough medicines could potentially cause illness.

On October 9, 2019, FDA recommended that Efficient Laboratories recall Rompe Pecho EX and Rompe Pecho CF cough syrups. To date, the company has not taken action to remove these potentially dangerous medicines from the market.

FDA is not aware of any reports of adverse events associated with these medicines at this time. Consumers who use Rompe Pecho EX and Rompe Pecho CF cough syrups and have concerns should contact their health care professional.

FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program: 

  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178

Source: FDA

Mucinex Fast-MAX Products: Recall - Incorrect Labeling

Apr 22, 2015

Audience: Consumer

Including certain lots 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

[Posted 04/22/2015]

ISSUE: 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 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.

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.

BACKGROUND: RB is notifying its distributors and customers by direct correspondence. See the press release for a listing of affected product lot numbers.

RECOMMENDATION: 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 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[04/21/2015 - Press Release - RB]

Guaifenesin (Unapproved) Timed-Release Drug Products

May 25, 2007

Audience: Consumers, healthcare professionals

[Posted 05/25/2007] FDA informed consumers and healthcare professionals of its intent to take action against companies that market unapproved timed-release dosage form of guaifenesin products, a substance commonly used in medicines to relieve cough and cold symptoms by stimulating removal of mucous from the lungs. These dosage forms are often described as extended-release, long-acting or sustained-release products that release their active ingredients over an extended period of time, reducing the number of doses needed per day. Approximately 20 firms make unapproved timed-release products containing guaifenesin that have not undergone FDA review for safety and efficacy. Mucinex, Mucinex-D, Mucinex-DM, and Humibid are the only FDA approved timed-release guaifenesin (single ingredient or combination) products. Companies marketing unapproved products containing guaifenesin in timed-release form are expected to stop manufacturing them within 90 days and must cease shipping them in interstate commerce within 180 days. This action does not affect products containing guaifenesin in immediate release form.

[May 25, 2007 - News Release - FDA]


May 23, 2005

Audience: Healthcare professionals and consumers

FDA issued a Talk Paper to notify the public about the abuse of dextromethorphan (DXM), an ingredient found in many over-the-counter (OTC) cough and cold remedies. The agency is working with other health and law enforcement authorities to address this serious issue and warn the public of potential harm, after five recently reported deaths of teenagers that may be associated with the consumption of powdered DXM sold in capsules.

[May 20, 2005 - Talk Paper - FDA]

More Mucinex Fast-Max Severe Congestion & Cough Resources