Beekeeper’s Naturals saline nasal spray sold on Amazon recalled over microbial contamination risk

INDIANA — Beekeeper’s Naturals has initiated a voluntary recall of a specific lot of its Saline Nasal Spray after routine testing revealed elevated levels of microbial contamination, according to a recent health notification. The affected lot, which was sold exclusively online through Amazon, was found to exceed acceptable microbiological limits for yeast and may contain Aspergillus species (Aspergillus spp.).

The product is commonly used by consumers as a sinus congestion rinse. Officials emphasize that no other Beekeeper’s Naturals products, including the “Nasal Spray Max,” are impacted by this voluntary measure.

To date, Beekeeper’s Naturals has received four customer reports detailing adverse reactions potentially linked to the recalled product. Reported symptoms include sinus congestion, irritation, and sinus infections.

Severe Health Risks for Vulnerable Groups

While the contamination poses a general health concern, it presents a heightened threat to specific patient populations. Medical professionals warn that individuals with weakened immune systems (immunocompromised) or pre-existing lung diseases face the highest risk.

For these vulnerable groups, using a nasal spray contaminated with Aspergillus spp. carries a reasonable probability of triggering serious, life-threatening infections, such as:

• Invasive Sinusitis: A severe infection that can rapidly spread from the sinus cavities to surrounding facial tissue, bone, or the central nervous system.
• Severe Lung Infections: Fungal infections within the respiratory tract that can severely compromise breathing and require aggressive medical intervention.

Otolaryngologists and primary care providers are advised to screen patients presenting with sudden, severe sinus or respiratory complications to determine if they have recently used the recalled product.

Affected Product Details

Consumers, patients, and pharmacies should immediately check their inventory for the following specific details:

• Product Name: Beekeeper’s Naturals Saline Nasal Spray
• Distribution Channel: Sold exclusively via Amazon
• Affected Lot Number: 5950
• Expiration Date / Best By: 02/2028

The lot number and expiration date can be located on the bottom or back label of the nasal spray packaging.

Recommendations for Consumers and Healthcare Providers

• Discontinue Use Immediately: Anyone in possession of Beekeeper’s Naturals Saline Nasal Spray from Lot 5950 should stop using the product immediately.
• Seek Medical Attention: Patients who have experienced unusual symptoms or potential adverse reactions after using this product should contact their physician or primary healthcare provider without delay.
• Request a Refund: Affected consumers can contact Beekeeper’s Naturals directly to arrange for a refund or ask questions by emailing contact@beekeepersnaturals.com or calling 1-888-759-6910.

Reporting Adverse Events

Healthcare professionals, patients, and consumers are strongly encouraged to report any adverse events or side effects associated with this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Reports can be submitted via the following methods:

1. Online: Complete and submit a report via the official FDA MedWatch website.
2. Phone: Call 1-800-332-1088 to request a reporting form.
3. Fax/Mail: Download the form online or request it by phone, complete it, and return it to the address provided on the form, or submit it via fax to 1-800-FDA-0178.