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If your child or another loved one has been harmed by recalled Safetussin Max Strength Multi-Symptom Cough, you should contact our law firm immediately. You may be entitled to compensation by filing a Safetussin Lawsuit, and our legal team can help.
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Details of the Safetussin Recall
On April 4, 2025, Kramer Laboratories voluntarily recalled Safetussin Max Strength Multi-Symptom Cough Cold and Flu 16-count blister packs [1.]. The recall affects about 3,000 units nationwide.
According to the U.S. Consumer Product Safety Commission (CPSC), the blister packs do not meet the Poison Prevention Packaging Act (PPPA) requirements for child-resistant packaging. This oversight creates a serious poisoning hazard if children access and ingest the medication.
The medicine contains active ingredients such as acetaminophen, dextromethorphan, guaifenesin, and phenylephrine, which can cause severe harm to young children if accidentally consumed.
CPSC officials stated:
“The failure to meet child-resistant packaging standards puts children at risk of serious injury or death from unintentional ingestion.”
How the Recall Happened
The violation came to light after a routine regulatory compliance inspection flagged the packaging defect. The medication, intended for adult use, was available at several retailers and online platforms.
Despite the risk, no injuries or incidents have been reported to date. However, regulators warn that continued availability of improperly packaged medications could lead to tragic consequences.
Kramer Laboratories is offering consumers a full refund or replacement product. Customers are advised to immediately store the medication out of children’s reach and contact the company for instructions on how to return or safely dispose of the product.
Legal Implications: Could There Be a Safetussin Lawsuit?
The Safetussin recall could lead to potential legal action, particularly under the following theories:
1. Product Liability
Manufacturers are legally responsible for ensuring their products meet safety standards. A failure to provide child-resistant packaging could qualify as a design defect or failure to warn under product liability laws.
2. Negligence
If Kramer Laboratories knew or should have known that the packaging was non-compliant and still distributed the product, they could be found negligent.
3. Breach of Warranty
By selling a non-compliant medication, Kramer Laboratories may have breached implied warranties that guarantee the product is safe and fit for its intended use.
If any child were harmed as a result of this packaging defect, affected families could pursue damages including:
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Medical expenses
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Pain and suffering
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Emotional distress
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Potential punitive damages
Federal Regulation and Child-Resistant Packaging
The Poison Prevention Packaging Act of 1970 requires certain household products and medications to be packaged in child-resistant containers.
The standard is designed so that at least 85% of children under five cannot open the packaging, while it must still be accessible to 90% of adults.
Violation of this federal law is taken very seriously because child poisoning remains a leading cause of accidental injury and death in young children.
According to the Centers for Disease Control and Prevention (CDC):
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Approximately 50,000 children are rushed to emergency rooms each year due to accidental medication poisoning.
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One child every 10 days dies from accidental medication exposure.
Regulators emphasize that proper packaging is a frontline defense against these tragedies.
What Should Consumers Do?
If you have Safetussin Max Strength Multi-Symptom Cough Cold and Flu blister packs:
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Stop using the product immediately.
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Store it out of reach of children.
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Contact Kramer Laboratories for a refund or replacement.
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Report any adverse incidents to the CPSC or the FDA’s MedWatch Adverse Event Reporting program.
Broader Impact on the Pharmaceutical Industry
This recall highlights an ongoing issue with packaging compliance in over-the-counter (OTC) medications.
Recent years have seen recalls for similar packaging violations involving:
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Children’s cold medicines
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Adult pain relievers
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Dietary supplements
Industry experts expect regulators to increase random inspections and pursue stiffer penalties for violations that endanger child safety.
If lawsuits are filed, they could prompt stricter enforcement of packaging standards across the board.
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Get a Free Safetussin Lawsuit Evaluation With Our Lawyers
The Products Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Safetussin Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Again, if your child or other loved one has been harmed by recalled Safetussin Max Strength Multi-Symptom Cough, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.
References:
1. https://www.cpsc.gov/Recalls/2025/Kramer-Laboratories-Recalls-Safetussin-Max-Strength-Multi-Symptom-Cough-Cold-and-Flu-Blister-Packs-Due-to-Risk-of-Child-Poisoning-Violation-of-Federal-Regulation-for-Child-Resistant-Packaging