CareFusion 213, LLC recalls BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x…
Lack of assurance of Sterility: potential product contamination
Read the official notice →- Date
- 2026-05-13
- Country
- United States
- Brand
- CareFusion
- Product
- BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x…
- Classification
- Class II
- Units
- Nationwide in the USA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More CareFusion recalls
- 2026-07-01
USCareFusion 213, LLC recalls BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner…
Non-Sterility: Due to presence of Aspergillus penicillioides.
FDA · DrugCareFusion 213, LLCNationwide inthe USA, as well as other foreign distribution.Official notice →- US
CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
FDA · DrugCareFusion 213, LLCNationwide inthe USA, as well as other foreign distribution.Official notice → - 2026-06-10
- US
CareFusion 303, Inc. recalls BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
FDA · DeviceCareFusion 303, Inc.US: Nationwide OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ,…Official notice → - 2026-04-01
- US
CareFusion 303, Inc. recalls BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
FDA · DeviceCareFusion 303, Inc.Worldwide distribution: U.S.(Nationwide) to states of: AL, AR, AZ, CA, CO, CT,…Official notice → - 2026-02-04
- US
CareFusion 303, Inc. recalls BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump…
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability…
FDA · DeviceCareFusion 303, Inc.U.S. Nationwide distribution in the states of AZ, IN, OH, and VA.Official notice → - 2026-01-14
- US
CareFusion 303, Inc. recalls BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01,…
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK,AL,AR,…Official notice →
Other drugs & medical recalls in the United States
- 2026-05-13
- US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles,…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- US
JB Chemicals and Pharmaceuticals Ltd recalls Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A…
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- US
Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- US
Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules,…
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- US
Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,…
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- US