BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Pa...
FDA Drug Recall #D-0441-2025 — Class II — May 15, 2025
Recall Summary
| Recall Number | D-0441-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 15, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CareFusion 213, LLC |
| Location | El Paso, TX |
| Product Type | Drugs |
| Quantity | 385,200 applicators |
Product Description
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
Reason for Recall
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Distribution Pattern
Nationwide in the U.S.
Lot / Code Information
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Other Recalls from CareFusion 213, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0517-2026 | Class II | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% ava... | Apr 22, 2026 |
| D-0518-2026 | Class II | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% ava... | Apr 22, 2026 |
| D-0243-2026 | Class II | BD ChloraPrep" Triple Swabsticks (Chlorhexidine... | Dec 17, 2025 |
| D-0259-2025 | Class I | BD ChloraPrep Clear 1mL Applicators, 2% w/v chl... | Feb 14, 2025 |
| D-1168-2023 | Class II | BD ChloraPrep Clear, 2% w/v chlorhexidine gluco... | Aug 25, 2023 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.