BD ChloraPrep Triple Swabsticks Recalled Due to Sterility Concerns

The US Food and Drug Administration (FDA) has issued a Class II recall for BD ChloraPrep™ Triple Swabsticks, a topical antiseptic containing chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v) in a 5.25 mL applicator. The product, manufactured by CareFusion 213, LLC in El Paso, Texas, was recalled due to a lack of assurance of sterility. The recall affects Lot #5086623, with an expiration date of March 31, 2028, and includes approximately 106 400 units distributed nationwide across the United States.

The recall was voluntarily initiated by CareFusion on December 17, 2025, and classified as Class II by the FDA on December 30, 2025. A Class II recall indicates that the product may cause temporary or medically reversible adverse health effects, but the likelihood of serious injury is considered low. While no contamination has been confirmed or adverse events reported, the failure to ensure sterility in a product intended for skin antisepsis—often used in surgical or procedural settings—poses a potential risk of infection, particularly in high-risk patient populations. The company has notified distributors and consignees by letter; no press release has been issued.

BD ChloraPrep Triple Swabsticks are used as a preoperative and pre-injection skin antiseptic, especially in hospital and surgical environments where broad-spectrum antimicrobial action is essential. Pharmacists working in clinical or procedural settings should identify and remove affected Lot #5086623 from inventory, notify relevant medical staff, and arrange for replacement with unaffected product. While the sterility concern may not represent an immediate health hazard, compromised antiseptic quality could undermine infection control protocols and patient safety during invasive procedures.

Reference
FDA. Enforcement Report. January 7, 2026. Accessed January 7, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm