About the Recalled Product

The recall covers ClearLife Allergy Nasal Spray, Extra Strength — a homeopathic nasal spray sold in a 20 mL (0.68 fl. oz.) bottle in a white and green carton — with NDC number 62795-4006-9 and UPC 787647101887. All lots within expiration are included; the recall covers bottles with expiration dates from December 2022 through December 2025, sold nationwide at retail stores and online at medinatura.com.

Latest Updates

The FDA assigned the ClearLife recall Class I status under recall number D-0289-2026, effective December 12, 2025, covering all lots of ClearLife Allergy Nasal Spray distributed nationwide — an action MediNatura took after expanding an earlier recall of its ReBoost Nasal Spray to include ClearLife following further internal investigation into microbial contamination [1][2]. MediNatura reported no adverse events at the time of the recall announcement, though the company and FDA warned that immunocompromised users face the highest risk of serious or life-threatening infection from continued use of the contaminated spray [3].

The Contamination: Achromobacter, Yeast, and Mold

Laboratory testing found three categories of microbial contamination in the recalled nasal sprays above acceptable specification levels: Achromobacter, a gram-negative bacterium; yeast; and mold. Achromobacter is an opportunistic pathogen — a microorganism that rarely causes illness in healthy individuals but can cause severe, treatment-resistant infections in people with weakened immune systems, including patients undergoing chemotherapy, organ transplant recipients, individuals with HIV/AIDS, and people on long-term corticosteroid therapy.

Nasal spray contamination is of particular concern because the product is applied directly to the mucous membrane lining of the nasal passages — a surface with a rich blood supply and direct access to the sinuses, throat, and lungs. Administering a bacterially contaminated product to this surface bypasses many of the body’s normal external defenses and delivers the pathogen in close proximity to the respiratory tract and central nervous system.

What Is a Class I Recall?

The FDA assigns Class I status when there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. It is the highest level of recall urgency the FDA can assign — above Class II (which involves a remote probability of serious harm) and Class III (unlikely to cause adverse health consequences). A Class I designation for a consumer nasal spray signals that federal regulators considered the contamination risk to represent an immediate and serious public health concern, not merely a technical violation of product specifications.

Who Was at Risk

ClearLife Allergy Nasal Spray is an over-the-counter homeopathic product marketed for allergy symptom relief — a category typically purchased and used without physician oversight, including by people who may not know they are immunocompromised or whose immune function is temporarily reduced due to illness, age, medication, or medical treatment. MediNatura’s own recall notice specifically identified immunocompromised individuals as the population at greatest risk of life-threatening infection from Achromobacter exposure.

Immunocompromised individuals who used the contaminated ClearLife spray may have experienced sinus infections, respiratory infections, bacteremia (bacteria in the bloodstream), or sepsis — infections that in this population can progress rapidly and be difficult to treat, particularly because Achromobacter strains have demonstrated resistance to multiple classes of antibiotics in clinical settings.

Can I File a Lawsuit?

If you or a family member experienced a serious infection — particularly a sinus infection, respiratory infection, or bloodstream infection — after using ClearLife Allergy Nasal Spray or ReBoost Nasal Spray and you are immunocompromised or otherwise vulnerable, you may have a product liability claim against MediNatura New Mexico for distributing a contaminated drug product. Contact a product liability attorney as soon as possible, as state filing deadlines apply.

How to Get a Refund

Stop using all recalled ClearLife and ReBoost nasal sprays immediately and do not use any remaining bottles regardless of expiration date. Retail purchasers should return the product to the place of purchase for a refund. Direct purchasers from medinatura.com should email recall@medinatura.com to arrange a refund. For questions, call MediNatura at 800-621-7644 Monday through Friday, 8 a.m. to 5 p.m. MST. Report any adverse reactions to the FDA at 1-800-FDA-1088 or online at fda.gov/medwatch.

References

1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medinatura-new-mexico-inc-expands-voluntary-nationwide-recall-reboost-nasal-spray-and-include

2. https://www.regdatalab.com/recall/D-0289-2026

3. https://www.earth.com/news/fda-issues-nationwide-recall-for-a-widely-used-medinatura-nasal-spray/

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