Recently, the US Food and Drug Administration (FDA) published four cosmetic-related recalls in its Enforcement Report. All four were firm-initiated and are currently in an ongoing status. CIRS Group has compiled and summarized the four recalls below to help companies promptly identify non-compliant ingredients and microbial-contamination risks, benchmark their own quality control, and avoid compliance and market-withdrawral risks.
Summary of the Four Recalls
| No. | Report Date | Event ID | Product Type | Recall Reason | Class | Quantity |
| 1 | 2026-05-13 | 98783 | Nail polish remover kit | FDA analysis found Methylene chloride and Chloroform in the nail polish remover. | Class II | 52,027 pcs |
| 2 | 2026-07-08 | 99135 | Unscented baby wipes | Wipes may be contaminated with Burkholderia cepacia complex and Burkholderia gladioli. | Class I | 6,405,369 packs |
| 3 | 2026-07-08 | 99135 | Cucumber-scented baby wipes | Wipes may be contaminated with Burkholderia cepacia complex and Burkholderia gladioli. | Class I | 440,567 packs |
| 4 | 2026-07-08 | 99190 | Oribe Serene Scalp Densifying Shampoo | Microbial contamination due to presence of Pluralibacter gergoviae | Class II | 828 units |
- The four recalls were all firm-initiated (Voluntary: Firm-initiated), and all are currently Ongoing.
- US recall classification: Class I = use or exposure will reasonably cause serious adverse health consequences or death; Class II = may cause temporary or medically reversible adverse health consequences.
Related Substance Analysis
According to Global CosIng, independently developed by CIRS Group, Methylene chloride (CAS 75-09-2) is currently listed in Title 21 of the US Code of Federal Regulations and is prohibited from use in cosmetics. It causes cancer in animals and is likely to be harmful to human health, too (21 CFR 700.19).
Chloroform (CAS 67-66-3) is likewise listed in Title 21 of the US Code of Federal Regulations and is prohibited from use in cosmetics. The use of chloroform in cosmetic products is prohibited because it causes cancer in animals and is likely to be harmful to human health, too. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient (21 CFR 700.18).
CIRS Reminder
These recalls underscore two recurring risk areas for cosmetics on the US market-the presence of banned ingredients and microbial contamination. CIRS Group offers the following reminders to help companies strengthen pre-market control, reduce non-compliance and market-withdrawral risks, and ensure product safety and smooth market access:
- Review formula compliance against banned ingredients: regularly screen product formulations against US prohibitions, paying particular attention to solvent-containing product categories, to avoid residues or misuse.
- Strengthen microbial quality control: as water-containing and emulsion-based products are more prone to microbial contamination, reinforce the preservative system, production-environment control, and routine microbial-limit testing.
- Benchmark across markets: monitor recall and safety notifications across major markets (e.g., the US, EU, and Canada) to support consistent global compliance.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- The United States Agent
- The United States FDA Cosmetic Facility Registration
- The United States FDA Cosmetic Product Listing
- The United States FDA OTC Drug Registration
- The United States Color Additive Batch Certification
- The United States Cosmetic/OTC Drug Labeling Review
- International Cosmetic Ingredient Name (INCI) Application
Further Information:
