FDA Issues Risk Warning for Sunscreen Recall in Multiple States
The U.S. Food and Drug Administration (FDA) has designated a recall of multiple sunscreen products as Class II, the second highest of its three risk categories.
The affected products included popular mineral and organic sunscreens marketed under several brand names and were distributed across New Jersey, Florida, and Michigan by Kabana Skin Care, headquartered in Louisville, Colorado.
The recall stemmed from identified deviations from Current Good Manufacturing Practice (cGMP) regulations, according to the agency’s enforcement report published July 10.
The FDA classified the action as voluntary and initiated by the firm after the agency identified cGMP deficiencies, including manufacturing or quality control lapses. No public press release had been issued by Kabana Skin Care at the time of reporting.
Newsweek has contacted Kabana Skin Care via email on Friday.
Why It Matters
Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause temporary or medically reversible adverse health consequences, but serious adverse outcomes are considered unlikely.
These recalls are less serious than Class I events but warrant careful attention for consumers and regulators when they involve widely used over-the-counter products such as sunscreen.
Other recent FDA sunscreen recalls have included incidents of chemical contamination or mislabeling of products, prompting broad national attention to product safety and ingredient integrity. Ensuring adherence to cGMP helps prevent distribution of drugs and cosmetics that may not meet safety or efficacy standards, particularly for items used frequently by vulnerable populations like children or those with sensitive skin. FDA guidance identifies cGMP as the backbone of pharmaceutical and over-the-counter product regulation, safeguarding consumers against potentially hazardous defects.
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What To Know
- Recall Details: The recall was initiated voluntarily by Kabana Skin Care on March 12 after the company notified consignees via letter. The FDA classified the recall as Class II on July 10.
- Distribution: The affected sunscreens were distributed in New Jersey, Florida, and Michigan.
- Products Impacted: The recall covered several sunscreen products and lots:
- B Natural Organics, Organic Sunscreen, Broad Spectrum SPF 30, 25% non-nano Zinc Oxide (lots 410-001, 404-003, 404-001; 204 tubes; Exp 10/31/2027, 04/30/2027)
- Erin’s Faces, Mineral SPF 32 (lot 410-002; 54 tubes)
- GreenScreen, Kabana Organic Skincare, Broad Spectrum UVA & UVB, SPF 32 (lots 405-002, 405-003; 174 tubes)
- In Your Face Mineral Tint SPF 31 (lot 408-002; 76 bottles)
- Reason for Recall: The FDA cited deviations from cGMP as the basis for the recall. Good manufacturing practices are essential requirements for assuring product safety and quality throughout manufacture, packaging, and labeling.
- How Class II Recalls Compare: According to the FDA, Class II recalls apply when “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.” This sits between Class III (least serious) and Class I (most serious) in the FDA’s risk hierarchy.
What People Are Saying
FDA’s statement on the importance of recalls and cGMP: “FDA is committed to ensuring drugs Americans use are safe and effective. FDA continues to monitor the issue… and is proactively working with companies, when appropriate, to recall products and encourage retailers to remove products from store shelves and online marketplaces when quality issues arise.”
What Happens Next?
Consumers in the affected states who purchased any of the recalled sunscreens are advised to discontinue use immediately and consult with the respective brands or Kabana Skin Care for further instructions.
The FDA continues to monitor the recall status while the manufacturer addresses the cGMP-related deficiencies. Further recall terminations or public safety updates will be provided on the FDA website as developments arise.
