Robitussin, a popular over-the-counter cough syrup brand owned by the consumer goods company Haleon, has voluntarily recalled select lots of Robitussin cough syrup in the U.S. due to potential microbial contamination. The recall includes specific lots of Robitussin Honey CF Max, Robitussin Nighttime Cough, and Robitussin Day/Night Combo packs.
Robitussin is one of the most widely used over-the-counter cough syrup brands in the United States. The company announced the voluntary recall on January 25th, 2024 after an internal investigation found microbial contamination in certain lots of the cough syrups.
Haleon stated that the contamination was traced to one of its manufacturing sites. The issue has since been resolved, but out of caution, Haleon decided to recall any potentially affected products.
This is the first major recall for Robitussin cough syrups. The decision to voluntarily recall select lots underscores Haleon’s commitment to consumer safety.
The recall impacts three Robitussin products sold nationally across the U.S:
- Robitussin Honey CF Max: 4 oz bottles
- Robitussin Nighttime Cough: 4 oz and 6 oz bottles
- Robitussin Day/Night Combo Pack: Containing both 4 oz bottles of Robitussin Honey CF Max daytime and Nighttime formulas
The specific lot numbers included in the recall are listed on the company’s press release. Consumers can also check if their Robitussin is affected using the lot number printed on the side of the box or bottle.
|Robitussin Honey CF Max 4 oz
|Robitussin Nighttime Cough 4 oz
|Robitussin Nighttime Cough 6 oz
|Robitussin Day/Night Combo Pack
Table 1: Recalled lot numbers by product
So far, no other Robitussin products have been recalled besides these three formulations.
Reason for Recall
In their recall notice, Haleon stated that an internal investigation found microbial contamination in the affected lots:
An internal investigation identified microbial contamination from one of the raw materials used to make the oral solution products.
While the company did not specify the type of contamination, they believe there is a risk of infection if the recalled products are consumed. Out of an abundance of caution, Haleon opted for a voluntary recall.
The source material causing the contamination came from one specific manufacturing site. That site has since been closed for remediation, and production has shifted to other facilities.
Haleon stated that no other Robitussin products have had complaints of contamination, and no other sites were impacted by this issue.
The health risks posed by the microbial contamination will depend on the type and level of microbes. However, contaminated medicines always carry additional risks for vulnerable populations.
As the FDA warns, consuming products contaminated with pathogens can lead to severe illness or even death in rare cases.
Infants, young children, pregnant women, the elderly, and anyone with a compromised immune system are most at risk of developing serious complications from contaminated products. Complications may include:
- Severe gastrointestinal illness
- Blood infections
- Lifelong chronic conditions
Healthy adults may only experience temporary nausea, vomiting, or diarrhea after ingesting contaminated cough syrups. But they can still transmit illnesses to at-risk loved ones.
While the risk depends on the contamination levels, Haleon opted for recall out of caution. Consumers who have the affected Robitussin should stop using it right away.
Consumers who purchased any recalled Robitussin cough syrups should stop using them immediately. The products can be returned to the place of purchase for a full refund.
Consumers can also contact Haleon Consumer Care at 1-877-924-7333 Monday through Friday for more information about refunds and returns.
Anyone experiencing health issues after using the recalled Robitussin should contact their doctor right away. Adverse reactions can also be reported to the FDA’s MedWatch Safety Information program.
Major retailers have been notified about the Robitussin recall and are taking action. Walmart, CVS, Walgreens, Rite Aid, and other national chains have removed recalled lots from shelves.
Retailers are posting notices about the recall in stores and online so consumers can check if their products are impacted. Anyone who still finds recalled Robitussin on shelves is encouraged to notify the retailer.
Online marketplaces like Amazon and eBay are also working to ensure third-party sellers do not continue listing the recalled lots. Still, consumers who purchase Robitussin from independent online sellers should carefully check lot numbers before using.
The recall was issued voluntarily by Haleon, but the FDA is also investigating. The regulatory agency oversees and enforces drug safety standards.
While the FDA has not yet released an official statement, they typically monitor major recalls. If the FDA finds issues with how Haleon handled production or recalls, they may take additional action.
Government health agencies like the CDC will also monitor the situation. They track infection rates that could potentially be linked to recalled medications. State health departments may also get involved if local contamination issues occur.
When will Robitussin production resume?
Haleon stated that production of Robitussin has shifted to alternate manufacturing sites not impacted by the contamination. Supply is expected to quickly return to normal levels as production ramps up again.
The company projects releasing new lots of Robitussin cough syrups within several weeks. They do not anticipate the recall causing any long-term shortages.
Could more products be recalled?
So far, Haleon has only recalled two formulations of Robitussin made at the affected site. No other facilities, brands, or products were impacted.
Still, in major recalls additional impacted products are sometimes found later. If Haleon discovers wider issues, they could expand the recall.
Haleon will continue testing all products to monitor for contamination before shipping. Consumers should sign up for recall alerts in case more Robitussin or Haleon products are impacted.
Will this recall affect Haleon stock?
Haleon, previously a division of GSK, became an independent company in mid 2022. After this first major recall, investors will be monitoring closely.
If the issue seems isolated and quickly resolved, it may have minimal long term stock impact. But if more quality control problems emerge, the brand’s reputation and share price could suffer.
For now, analysts don’t anticipate a major financial hit. But Haleon will need to demonstrate that consumer safety remains an utmost priority going forward.
This voluntary recall of select Robitussin products demonstrates Haleon’s commitment to consumer safety. While concerning, the swift actions to remove potentially contaminated products from shelves should prevent major health impacts.
Still, consumers are advised to check all Robitussin against recalled lot numbers. Anyone experiencing issues after using the cough syrup should immediately contact their doctor and report it.
Haleon stated that production will continue at alternate sites. They expect new shipments to resume within weeks. The FDA and other agencies will continue investigating while monitoring for any linked infections.
This proactive recall aims to put consumer health first. Haleon will need to back up that priority through transparent communication and preventative quality control measures moving forward.
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