Critical Alert
CareFusion 213 Recalls BD ChloraPrep FREPP Clear
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #D-0625-2026Drug / Pharmaceutical
CareFusion 213 Recalls BD ChloraPrep FREPP Clear
CareFusion 213, LLC · Class I — Most Serious
Product Description
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Reason for Recall
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Nationwide inthe USA, as well as other foreign distribution.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class I recall — the most serious classification reserved for situations where there is a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death. CareFusion 213, LLC initiated this recall of pharmaceutical product on May 28, 2026 affecting 178,000 applicators. Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. The product was distributed nationwide. Consumers who have this product should stop using it immediately and contact the recalling firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects and CareFusion recalls.