Navigating the Pharmacy Aisle: Trust and Scrutiny in OTC Medications
Consumers rely on over-the-counter (OTC) medications for accessible relief from common ailments like the cold and flu. However, recent events in 2024 and 2025 have highlighted the importance of vigilance, with multiple recalls and significant regulatory reviews affecting common products. These actions, initiated by both manufacturers and federal bodies like the Food and Drug Administration (FDA), serve to protect public health but can create confusion for consumers. Understanding these recalls is crucial for making safe and effective choices for you and your family.
The Broader Context: The Phenylephrine Question
Underlying many discussions about cold medicine is the status of a common ingredient, phenylephrine. In late 2024, an FDA advisory committee unanimously concluded that oral phenylephrine is not effective as a nasal decongestant [1.3.8, 1.4.2]. The FDA's own scientists found that less than 1% of the drug is absorbed into the bloodstream when taken orally, a dose too low to have a clinical effect [1.3.8]. Following this, the FDA issued a proposal to remove oral phenylephrine from its list of approved OTC monograph active ingredients [1.3.9]. While the agency has stressed that phenylephrine does not pose a direct safety risk at approved doses, its lack of efficacy means consumers may be spending money on a product that works no better than a placebo for nasal congestion [1.3.8]. This regulatory shift is the backdrop for a market in transition, with many brands that contain the ingredient still on shelves pending a final order.
June 2025 Recall: Little Remedies Honey Cough Syrup
In June 2025, Medtech Products Inc., a Prestige Consumer Healthcare company, issued a voluntary recall for five lots of its Little Remedies Honey Cough Syrup [1.3.2, 1.4.3]. The reason for the recall was the presence of Bacillus cereus, a type of bacteria that can cause food-borne illness, and a loss of shelf-stability [1.3.2].
Bacillus cereus can lead to two types of illness: one characterized by vomiting and nausea, and another by diarrhea and stomach cramps [1.5.8]. While these infections pose a minimal risk to healthy individuals, they can be more serious for those with compromised immune systems. No serious adverse events were reported in connection with this recall [1.4.3]. Consumers who purchased the affected lots were instructed to stop using the product immediately and were offered a reimbursement [1.4.3, 1.5.6].
April 2025 Recall: Safetussin Packaging Violation
Kramer Laboratories recalled approximately 14,250 packages of Safetussin Max Strength Multi-Symptom Cough, Cold and Flu tablets in April 2025 [1.2.4]. This recall was not due to an issue with the medicine itself, but rather its packaging. The U.S. Consumer Product Safety Commission (CPSC) found that the blister packs were not child-resistant, a violation of the Poison Prevention Packaging Act [1.2.5, 1.4.6].
The medication contains acetaminophen, which can cause serious health issues, including liver damage, if ingested in large quantities by children [1.2.4, 1.6.8]. Because the tablets could be pushed through the foil backing, they posed a significant poisoning risk [1.2.4]. The recalled products were sold at stores like H-E-B and Harris-Teeter between July 2024 and March 2025 [1.2.5, 1.4.6]. Consumers were advised to secure the product away from children and contact Kramer Laboratories for a full refund and disposal instructions [1.2.5].
Other Notable 2024-2025 Recalls
Other significant recalls have occurred, contributing to consumer uncertainty.
- Costco Kirkland Signature (January 2025): Costco recalled its Kirkland Signature Severe Cold & Flu Plus Congestion capsules due to potential contamination with foreign material [1.2.9, 1.4.1]. The recall was classified as a Class II recall due to violations of Current Good Manufacturing Practices (CGMP) [1.4.2]. The affected lot was sold in late 2024 [1.4.1].
- Robitussin Honey (January 2024): Manufacturer Haleon voluntarily recalled eight lots of Robitussin Honey CF Max products for adults due to microbial contamination (yeast) [1.6.2, 1.6.5]. This contamination posed a risk of severe or life-threatening infections for immunocompromised individuals [1.6.3, 1.6.6].
Comparison of Recent Cold Medicine Recalls
| Brand/Product | Date of Recall | Reason for Recall | Primary Risk | Consumer Action |
|---|---|---|---|---|
| Little Remedies Honey Cough Syrup | June 2025 | Microbial contamination (Bacillus cereus) [1.3.2] | Food-borne illness (nausea, vomiting, diarrhea) [1.5.8] | Stop use, contact manufacturer for refund [1.4.3] |
| Safetussin Max Strength Tablets | April 2025 | Packaging not child-resistant [1.2.5] | Risk of child poisoning from acetaminophen [1.2.4] | Secure from children, contact manufacturer for refund [1.4.6] |
| Kirkland Signature Severe Cold & Flu | January 2025 | Potential foreign material contamination [1.4.1] | Product quality and safety deviations [1.4.2] | Return to Costco for a full refund [1.4.1] |
| Robitussin Honey CF Max | January 2024 | Microbial contamination (yeast) [1.6.5] | Severe infection in immunocompromised individuals [1.6.6] | Stop use, contact manufacturer for return instructions [1.6.3] |
What Should Consumers Do?
Given these events, consumers should take proactive steps to ensure their medicine cabinet is safe.
- Check Your Products: Periodically review your medications. Compare the product name, lot number, and expiration date on the packaging against the FDA's and CPSC's official recall lists [1.6.3].
- Dispose of Recalled Products Safely: Follow the manufacturer's instructions for disposal or return. Do not simply throw medications in the trash where they could be accessed by children or pets.
- Report Adverse Events: If you experience any health problems after using a product, contact your healthcare provider. You can also report adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program [1.4.3].
- Choose Alternatives Wisely: For nasal congestion, consider products with pseudoephedrine, which remains effective but is sold behind the pharmacy counter [1.4.9]. Nasal sprays like fluticasone (Flonase) or antihistamine sprays are also effective alternatives for allergy symptoms [1.4.9]. However, be mindful that decongestant nasal sprays can cause rebound congestion if used for more than a few days [1.4.9].
Conclusion
The recent recalls of cold medicines in 2025 serve as a critical reminder that the OTC market is subject to rigorous oversight for safety and efficacy. While the system works to identify and remove problematic products, the ultimate responsibility for household safety lies with the consumer. By staying informed about which cold medicine was recently recalled, understanding the reasons, and knowing what alternative treatments are effective, you can navigate cold and flu season with confidence and ensure your family's well-being.
For the most up-to-date information on drug recalls, consult the official FDA website. The information in this article is current as of September 2025. You can find more information at the FDA Drug Recalls Page.
