BD ChloraPrep Clear and BD ChloraPrep FREPP Clear Recalled Due to Non-Sterility
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class I recall for BD ChloraPrep Clear, 1 mL, and BD ChloraPrep FREPP Clear, 1.5 mL. The affected batches have been identified as Lots 4032183 and 4073005, which expire January 2027 and March 2027, affecting 371 440 applicators.
- The recall was initiated by CareFusion 213, LLC due to non-sterility, a quality issue that will cause serious adverse health consequences or death.
- BD ChloraPrep Clear and BD ChloraPrep FREPP Clear are used as antiseptics to prepare a patient’s skin before surgery.
The FDA has issued a Class I recall for BD ChloraPrep Clear, 1 mL, and BD ChloraPrep FREPP Clear, 1.5 mL (chlorhexidine gluconate and isopropyl alcohol solutions), affecting 371 440 applicators. This product is being recalled by CareFusion 213, LLC based in El Paso, Texas. The recall was initiated on May 28, 2026, and received a Class I classification on June 25, 2026. A Class I classification means the use of this product will cause serious adverse health consequences or death.
The recall was initiated due to the presence of Aspergillus penicillioides in the product, making it non-sterile. Additionally, BD ChloraPrep FREPP Clear has wrinkles in the paper lidding which may breach the seal area. This deficiency affects Lots 4032183 and 4073005, which will expire in January 2027 and March 2027, respectively. CareFusion sent out a public notice via letter and issued a press release on June 6, 2026.
BD ChloraPrep Clear and BD ChloraPrep FREPP Clear are used as antiseptics to prepare a patient’s skin before surgery or invasive medical procedures by reducing bacteria that could cause skin infections. Pharmacists should identify and quarantine Lots 4032183 and 4073005, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
- FDA. Enforcement Report. July 1, 2026. Accessed July 1, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221074
- FDA. Enforcement Report. July 1, 2026. Accessed July 1, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221075
