by The U.S. Food and Drug Administration (FDA) has issued a Class II recall for a range of sunscreen products marketed under various brand names and distributed in New Jersey, Florida, and Michigan. The affected products were manufactured by Kabana Skin Care, a Louisville, Colorado-based company, and were recalled due to deviations from Current Good Manufacturing Practice (cGMP) regulations.
The FDA’s enforcement report, published on July 10, noted the recall was voluntarily initiated by the manufacturer on March 12 after the company notified consignees through written communication. Despite the seriousness of the regulatory findings, no public press release had been issued by Kabana Skin Care at the time of reporting.
Class II recalls are used for products where use or exposure may cause temporary or medically reversible adverse health effects, though the risk of serious harm is considered low. Since sunscreen is widely used—often by children and individuals with sensitive skin—maintaining proper manufacturing standards is essential for public safety.
Key Recall Details:
- Recall Classification: Class II (moderate risk to health)
- Initiation Date: March 12, 2025 (voluntarily initiated by Kabana Skin Care)
- FDA Classification Date: July 10, 2025
- States Affected: New Jersey, Florida, Michigan
- Manufacturer: Kabana Skin Care, Louisville, Colorado
- Reason for Recall: Violations of cGMP regulations (manufacturing and quality control deficiencies)
Products Impacted:
- B Natural Organics Organic Sunscreen Broad Spectrum SPF 30
- Zinc Oxide 25% (non-nano)
- Lots: 410-001, 404-003, 404-001
- Quantity: 204 tubes
- Expiry Dates: 10/31/2027, 04/30/2027
- Erin’s Faces Mineral SPF 32
- Lot: 410-002
- Quantity: 54 tubes
- GreenScreen by Kabana Organic Skincare SPF 32 (UVA & UVB)
- Lots: 405-002, 405-003
- Quantity: 174 tubes
- In Your Face Mineral Tint SPF 31
- Lot: 408-002
- Quantity: 76 bottles
According to FDA guidelines, a Class II recall is issued when use of or exposure to a product may cause temporary or medically reversible health effects, or when the risk of serious adverse effects is low but present. It falls between Class I (most serious) and Class III (least serious) in terms of public health risk.
Consumers who have purchased the recalled sunscreen products in the affected states are urged to stop using them immediately and reach out to the brands or Kabana Skin Care for further guidance. The FDA will continue to monitor the situation and may issue additional updates or terminate the recall if corrective actions are completed. Updates can be found on the official FDA website.
This recall highlights the importance of quality control in over-the-counter health products, particularly those intended for daily and repeated use.
