Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Pine Pharmaceuticals, Llc
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuti...
Ophthalmic Drugs·2,181 affected·Oct 2, 2023
CriticalFDA
Pfizer Inc.
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx on...
Injectable Drugs·21,390 affected·Oct 2, 2023
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA III Gastrointestinal Videoscope
Medical Devices·1,687 affected·Oct 2, 2023
CriticalFDA
Coapt Llc
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Medical Devices·247 affected·Oct 2, 2023
High RiskFDA
Carestream Health, Inc.
DRX Revolution Mobile X-Ray System
Medical Devices·3,961 affected·Oct 2, 2023
CriticalFDA
Carestream Health, Inc.
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system cons...
Diagnostic Devices·2,402 affected·Oct 2, 2023
High RiskFDA
Stanbio Laboratory, Lp
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Diagnostic Devices·2,351 affected·Oct 2, 2023
CriticalFDA
Bix Produce Company Llc
FreshPoint Bix Produce Company, Cantaloupe. Item # 03143. 3 melons per bag.
Produce·61 affected·Sep 29, 2023
CriticalFDA
Biomic Sciences, Llc Dba Ion Intelligence Of Nature
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Inhaled / Nasal Drugs·0 affected·Sep 29, 2023
High RiskFDA
Biomic Sciences, Llc Dba Ion Intelligence Of Nature
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
Inhaled / Nasal Drugs·0 affected·Sep 29, 2023
High RiskFDA
Biomic Sciences, Llc Dba Ion Intelligence Of Nature
ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
Inhaled / Nasal Drugs·0 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Medical Implants·9 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Medical Implants·1 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Medical Devices·1 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Medical Devices·1 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Medical Implants·2 affected·Sep 29, 2023
High RiskFDA
Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Medical Devices·2,448 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Medical Devices·8 affected·Sep 29, 2023
High RiskFDA
Encore Medical, Lp
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Medical Devices·406 affected·Sep 29, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Surgical Devices·2,460 affected·Sep 29, 2023
High RiskFDA
Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Medical Devices·2,448 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Medical Devices·2 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Medical Implants·51 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Medical Implants·133 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Medical Devices·1 affected·Sep 29, 2023
High RiskFDA
Sentinel Ch Spa
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Diagnostic Devices·4,394 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Medical Devices·1 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Medical Implants·6 affected·Sep 29, 2023
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Medical Devices·5 affected·Sep 29, 2023
High RiskFDA
Staar Surgical Company
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Medical Implants·15 affected·Sep 29, 2023
RecallFDA
Actipharma, Inc.
ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
Supplements·607 affected·Sep 28, 2023
CriticalFDA
Orgain
Organic Protein & 50 Superfoods Protein Powder with Probiotic - Chocolate flavor
Snacks & Candy·54,546 affected·Sep 28, 2023
High RiskFDA
Padagis Us Llc
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per ...
Topical Drugs·10,512 affected·Sep 28, 2023
High RiskFDA
Eugia Us Llc
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or I...
Injectable Drugs·1,626 affected·Sep 28, 2023
High RiskFDA
Abbott
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Medical Devices·34 affected·Sep 28, 2023
High RiskFDA
Olympus Corporation Of The Americas
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Medical Devices·75 affected·Sep 28, 2023
CriticalFDA
Paradise Flavors Llc
MAMEY, PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
Frozen Food·80 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
Cookies And Cream, distributed by Paradise Flavors LLC, 4 OZ, 120ML, Packaged in plastic pouch. Frozen.
Dairy·318 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
UNICORN Ice-cream base, natural flavors, Artificial Flavoring, Artificial color. DISTRIBUTED BY PARADISE FLAVORS LLC. 4 oz. Packaged in p...
Dairy·216 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
Pina Colada, ice-cream base, natural flavoring, artificial flavoring. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
Dairy·120 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
YOGOBERRY (YOGURT WITH FRUITS), Ice cream, Mix Berries, Granola, Honey, Citric acid., PARADISE FLAVORS LLC, 4 oz. Packaged in plastic po...
Dairy·0 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
PINK GUABA, Ice-cream mix, filtered water, Natural Flavoring, sugar, Artificial color. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch....
Dairy·0 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
Strawberries and Cream, ice-cream base, natural flavoring. Paradise Flavors LLC. 4 oz. Packaged in plastic pouch. Frozen.
Dairy·86 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
BLACKBERRY CHEESECAKE, Ice-cream base, Natural Flavor, Cheese, Butter, crackers., 4 oz (120 ML), PARADISE FLAVORS LLC. Packaged in plasti...
Dairy·58 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
COCONUT/COCO ice cream mix, natural flavors, artificial flavors. 9601 Overseas Hwy, Marathon FL. 100ml 3 oz. Packaged in plastic pouch. F...
Dairy·216 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
PEANUT BUTTER/MAZAPAN, Ice-cream base, Natural Flavor, Artificial Color, sea salt., Distributed by PARADISE FLAVORS LLC, 4 OZ. Packaged i...
Dairy·210 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
BUTTER PECAN, Ice-cream base, Natural flavor, graham crackers, artificial color, citric acid, artificial flavoring. Paradise Flavors. 4 o...
Dairy·58 affected·Sep 27, 2023
CriticalFDA
Paradise Flavors Llc
VANILLA, Ice-cream base, Natural flavor, artificial flavor and coloring. Distributed By Paradiose Flavors LLC. 4 oz. Packaged in plastic ...
Dairy·310 affected·Sep 27, 2023