BD ChloraPrep FREPP Clear Recall Due to Sterility Issue
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CareFusion 213, LLC is recalling multiple lots of BD ChloraPrep FREPP Clear applicators due to lack of assurance of sterility from potential seal breaches.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
CareFusion 213, LLC initiated a voluntary recall of BD ChloraPrep FREPP Clear due to lack of assurance of sterility caused by wrinkles in the paper lidding which may breach the seal area. The recall is classified as Class II by the FDA and affects product distributed nationwide in the USA as well as foreign markets.
Which Products Are Affected
The affected product is 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, NDC 54365-400-30. Numerous lots are impacted with expiration dates ranging from 05/31/2026 through 10/31/2027. Specific lot numbers include 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, 3230424, 3234042, 3240990, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, 3261058, 3263492, 3264573, 3268341, 3270418, 3275533, 3276460, 3278683, 3283037, 3284107, 3292960, 3292965, 3286221, 3290240, 3293922, 3297295, 3298930, 3299555, 3299562, 3301403, 3304245, 3306751, 3307190, 3310919, 3310926, 3314371, 3319520, 3321408, 3321409, 3324363, 3324369, 3332082, 3334305, 3335243, 3336896, 3337416, 3337417, 3340134, 3343540, 3346461, 3347121, 3350902, 3353143, 4004043, 4008394, 4009336, 4011488, 4012213, 4017668, 4019659, 4024538, 4025597, 4028103, 4030830, 4031885, 4032130, 4034194, 4037955, 4039988, 4039341, 4042520, 4045073, 4045127, 4050288, 4053896, 4058398, 4060624, 4062561, 4066133, 4068918, 4070112, 4074981, 4075814, 4078276, 4072390, 4073005, 4079088, 4080879, 4081625, 4086628, 4087806, 4096981, 4100347, 4100349, 4103385, 4103386, 4110975, 4113747, 4131843, 4121050, 4123171, 4123172, 4128501, 4128502, 4130512, 4135272, 4141597, 4150024, 4149611, 4150025, 4152202, 4157691, 4159978, 4160566, 4163121, 4173445, 4173447, 4178299, 4178303, 4180764, 4193574, 4197392, 4200111, 4204425, 4205156, 4206764, 4206766, 4207230, 4213335, 4211319, 4215668, 4218795, 4220980, 4242090, 4226396, 4227235, 4229934, 4232786, 4236636, 4236982, 4236489, 4242092, 4242505, 4248359, 4250795, 4254763, 4256132, 4260191, 4261289, 4261760, 4262812, 4269519, 4270776, 4271977, 4274445, 4276054, 4282861, 4284334, 4290362, 4291615, 4297871, 4299657, 4300686, 4302997, 4303204, 4305323, 4305318, 4310195, 4311615, 4312855, 4313930.
What You Should Do
Consumers should not use the affected product. Contact CareFusion 213, LLC for further information regarding the recall.
Why This Matters
The recall addresses a potential sterility issue with a topical antiseptic product distributed widely across the United States.
Source
FDA recall number D-0623-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (2,860 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.