FDA Recalls Robitussin Cough Medication: What You Need to Know
The FDA recalled several batches of Robitussin due to microbial contamination. Learn which products are affected, health risks, and your legal rights if yo
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Licatesi Law Group, LLP publishes these articles to help readers understand common injury, insurance, and litigation issues in New York and New Jersey. This information is not legal advice. If you have a potential claim, speak with an attorney about the facts of your case.
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What to know before you act
FDA Recalls Robitussin Cough Medication: What You Need to Know often depends on preserving the product, packaging, warnings, purchase records, medical proof, and any recall or safety information tied to the injury.
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- Do not throw away the product, packaging, receipt, instructions, or warning labels.
- Photograph the product, lot number, serial number, and condition after the incident.
- Save medical records and any recall, FDA, manufacturer, or retailer notices.
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- Product, packaging, labels, and receipts
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- Recall or safety notices
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FDA Issues Robitussin Recall Due to Contamination
The U.S. Food and Drug Administration (FDA) issued recalls for multiple batches of Robitussin cough syrup products due to microbial contamination that poses serious health risks to consumers. If you or a loved one consumed recalled Robitussin and experienced adverse health effects, you may have legal recourse.
At Licatesi Law Group, we represent New York residents harmed by contaminated medications and defective pharmaceutical products. This guide explains the Robitussin recall, associated health risks, and your legal options.
Why Was Robitussin Recalled?
Haleon (formerly part of GSK Consumer Healthcare) voluntarily recalled certain Robitussin products after discovering microbial contamination in manufacturing facilities. The contamination involves bacteria and fungi that can cause serious infections, particularly in vulnerable populations.
Recalled Robitussin Products
Check your medicine cabinet for these recalled products:
Robitussin Honey CF Max Day Adult Robitussin Honey CF Max Nighttime Adult Robitussin Honey Severe Multi-Symptom Cough Cold + Flu Robitussin Multi-Symptom Cold CF Various store-brand equivalents manufactured at the same facility
Important: Check the lot number and expiration date on your bottle against the FDA's published recall list at FDA.gov.
- Robitussin Honey CF Max Day Adult
- Robitussin Honey CF Max Nighttime Adult
- Robitussin Honey Severe Multi-Symptom Cough Cold + Flu
- Robitussin Multi-Symptom Cold CF
- Various store-brand equivalents manufactured at the same facility
Health Risks from Contaminated Robitussin
Microbial contamination in oral medications can cause serious health complications, especially in immunocompromised individuals.
Who is Most at Risk?
Children and infants Elderly individuals People with weakened immune systems (cancer patients, HIV/AIDS, organ transplant recipients) Individuals with chronic lung conditions (asthma, COPD, cystic fibrosis) Anyone already ill with respiratory infections
- Children and infants
- Elderly individuals
- People with weakened immune systems (cancer patients, HIV/AIDS, organ transplant recipients)
- Individuals with chronic lung conditions (asthma, COPD, cystic fibrosis)
- Anyone already ill with respiratory infections
Potential Health Complications
Respiratory infections - Pneumonia, bronchitis, lung infections Bloodstream infections (sepsis) - Life-threatening systemic infection Gastrointestinal infections - Nausea, vomiting, diarrhea Fungal infections - Can spread to organs in immunocompromised patients Allergic reactions - Severe allergic responses to microbial byproducts
- Respiratory infections - Pneumonia, bronchitis, lung infections
- Bloodstream infections (sepsis) - Life-threatening systemic infection
- Gastrointestinal infections - Nausea, vomiting, diarrhea
- Fungal infections - Can spread to organs in immunocompromised patients
- Allergic reactions - Severe allergic responses to microbial byproducts
Symptoms of Microbial Contamination Illness
If you consumed recalled Robitussin, watch for these symptoms:
Fever and chills Worsening cough or difficulty breathing Chest pain or tightness Severe nausea, vomiting, or diarrhea Rapid heartbeat Confusion or altered mental state Persistent fatigue
Seek immediate medical attention if you experience these symptoms, especially if you're immunocompromised.
- Fever and chills
- Worsening cough or difficulty breathing
- Chest pain or tightness
- Severe nausea, vomiting, or diarrhea
- Rapid heartbeat
- Confusion or altered mental state
What Caused the Contamination?
The FDA investigation revealed manufacturing quality control failures that allowed microbial growth in production facilities. Issues included:
Inadequate facility sanitation Insufficient quality testing protocols Failure to detect contamination before distribution Inadequate sterile manufacturing processes
- Inadequate facility sanitation
- Insufficient quality testing protocols
- Failure to detect contamination before distribution
- Inadequate sterile manufacturing processes
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