Class I — High Risk Severity Status: Ongoing Authority: FDA

CLEARLIFE EXTRA STRENGTH

Recalling Firm / Manufacturer: Medinatura New Mexico, inc. (Albuquerque, NM, United States)
FDA Recall Number: D-0289-2026
View FDA Source
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
CLEARLIFE EXTRA STRENGTH
Generic Name
ONION, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SULFUR, AMBROSIA ARTEMISIIFOLIA WHOLE, EUPHRASIA STRICTA AND SCHOENOCAULON OFFICINALE SEED
Active Substance(s)
Onion, Galphimia Glauca Flowering Top, Histamine Dihydrochloride, Luffa Operculata Fruit, Sulfur, Ambrosia Artemisiifolia Whole, Euphrasia Stricta, Schoenocaulon Officinale Seed
Administration Route
Nasal
National Drug Code (NDC)
62795-4006
Total Quantity Recalled
Official Reason for Recall
Specific hazard or quality defect cited by the FDA

According to the official FDA enforcement report:

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

Full Product Description
Packaging specifications and labeling details

ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887

Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class I
Current Action Status
Ongoing
FDA Enforcement Report Date
January 14, 2026
Firm Initiation Date
December 12, 2025
FDA Classification Date
Jan 15, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
All lots within expiry.
Distribution Information
Geographic scope of affected shipments

Nationwide in the US

Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
⚠️ Immediate Action Required — Patient Notice
According to official FDA guidelines for Class I recalls, patients using affected lots should stop taking this product immediately and contact their physician or pharmacist for an appropriate alternative. Do not dispose of medication until instructed by your pharmacy.
Healthcare Provider & Pharmacy Notice
Quarantine affected inventory immediately. Contact patients who were dispensed recalled lots to arrange replacement. Report any adverse reactions directly to the FDA MedWatch Safety Information Program.

Official Source Provenance

Verified regulatory citation from U.S. FDA OpenFDA

Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0289-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508608UTCC
View Official FDA Source

System Notice

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