BD Recalls 43 Million ChloraPrep Applicators Over Sterility Concerns

CareFusion 213, LLC, a subsidiary of Becton, Dickinson and Company, has voluntarily recalled 43,066,599 units of BD ChloraPrep Clear antiseptic applicators due to a lack of assurance of sterility. The affected product may exhibit an open or incomplete seal on the packaging, which could compromise the sterile solution inside before use on patients.

What Products Are Being Recalled?

The recall covers BD ChloraPrep Clear, a sterile antiseptic solution containing 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol. The product is packaged in cartons of 60 x 1 mL single-use applicators, each containing 0.03 fl oz (1 mL) of solution. The product carries NDC 54365-400-31 and was manufactured by CareFusion 123, LLC in El Paso, TX. Numerous lot numbers are affected, including 4062535, 4065201, 4066446, 4141090, 4180288, 4197695, 4197697, 4180291, 4219454, 4221945, 4221966, 4222853, 4224361, 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, 5124984, 5127231, 5129058, 5126398, 5129488, 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, and 5176326, among others, with expiration dates ranging from February 2027 through May 2028.

Why Was This Recall Issued?

The recall was initiated after it was discovered that some applicators may have an open or incomplete seal on their packaging. Because ChloraPrep is intended to be used as a sterile skin antiseptic prior to injections, surgical procedures, and other invasive medical procedures, any breach in the seal could allow contamination to enter the applicator. Using a non-sterile antiseptic product for skin preparation before a medical procedure could increase the risk of infection at the treatment site.

Who Is Affected?

This recall affects hospitals, clinics, surgical centers, and other healthcare facilities across the United States that use BD ChloraPrep Clear applicators as part of their patient skin preparation protocols. The product was distributed nationwide. This is a Class II recall, meaning use of the affected product may cause temporary or medically reversible adverse health consequences, though the probability of serious adverse health consequences is remote.

What Should You Do?

Healthcare facilities and medical staff who have BD ChloraPrep Clear applicators in the affected lots should take the following steps:

• Check the lot numbers and expiration dates on your stock against the recalled list.
• Inspect individual applicator packaging for any signs of an open or incomplete seal before use.
• Do not use any applicator with a compromised seal, and quarantine affected units.
• Follow instructions provided in the firm’s recall notification letter regarding return or disposal of affected product.
• Contact CareFusion 213, LLC or BD customer service for guidance on replacement product.
• Report any adverse events related to use of this product to the FDA’s MedWatch program.

Official Statement

According to the recall notice, the reason for the action is ‘Lack of Assurance of Sterility’ due to affected product potentially exhibiting ‘an open or incomplete seal on the packaging of the applicator.’ The recall was initiated on July 9, 2026, and was classified by the FDA as a Class II recall on July 15, 2026. The firm notified consignees by letter, and no press release has been issued for this recall. The recall remains ongoing, with recall number D-0690-2026.