The FDA Desk — 2026-07-14

TITLE: FDA Desk: CareFusion Sterility Recall Sweeps Seven ChloraPrep/PurPrep Lines; No Class I Actions Today

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No Class I recalls were posted today. All ten actions below are Class II, firm-initiated voluntary recalls.

CareFusion Sterility Failure — Seven Product Lines Affected

CareFusion 213, LLC (a Beckton Dickinson subsidiary, El Paso, TX) is recalling seven distinct ChloraPrep and PurPrep antiseptic applicator lines after unsterilized units — intended for further processing and terminal sterilization — were shipped directly to customers instead. Affected lots span multiple formats and concentrations:

• D-0643-2026: BD ChloraPrep Hi-Lite Orange (2% CHG/70% IPA), 100 x 10.5 mL applicators/case, NDC 54365-400-35.
• D-0646-2026: ChloraPrep FREPP Clear (2% CHG/70% IPA), 500 x 1.5 mL applicators/case, NDC 54365-400-30.
• D-0652-2026: BD ChloraPrep Clear (2% CHG/70% IPA), 100 x 10.5 mL applicators/case, NDC 54365-400-34.
• D-0651-2026: BD ChloraPrep Clear (2% CHG/70% IPA), 500 x 1 mL applicators/case, NDC 54365-400-31.
• D-0650-2026: BD ChloraPrep Scrub Teal (2% CHG/70% IPA), 25 x 26 mL and 50 x 26 mL applicators/case, NDC 54365-400-39.
• D-0644-2026: BD PurPrep (8.3% w/w povidone-iodine with 72.5% w/w isopropyl alcohol), 50 x 26 mL applicators/case.

Because these are pre-surgical skin antiseptics, unsterilized applicators pose a direct infection risk at the point of use; all lots were pulled June 11, 2026.

Other Class II Actions

• D-0661-2026: Cipla USA is recalling Cinacalcet Hydrochloride Tablets, 30 mg (NDC 69097-410-02, manufactured by Cipla Ltd., India) due to cGMP deviations showing N-nitroso-cinacalcet above the acceptable daily intake limit, raising a nitrosamine impurity concern.
• D-0658-2026: Asclemed USA is recalling Accucaine kits containing Lidocaine HCl Injection USP 1% ampules (distributed by Enovachem Pharmaceuticals, NDC 76420-715-01) over lack of sterility assurance in the single-dose ampules.
• D-0655-2026: Lupin Pharmaceuticals is recalling prednisoLONE Acetate Ophthalmic Suspension USP 1% in 5, 10, and 15 mL sizes (NDC 70748-332-02/03/04, made at Lupin's Pithampur, India facility) due to a foreign substance found in the sterile suspension.
• D-0656-2026: Accord Healthcare is recalling Levothyroxine Sodium Tablets USP, 300 mcg, 90-count bottles (manufactured by Intas Pharmaceuticals, India) for subpotency, a concern for patients relying on precise thyroid hormone dosing.