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
CriticalFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC ...
Ophthalmic Drugs·1,271,810 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Healt...
Drugs·21,802 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, ...
Ophthalmic Drugs·8,784 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardin...
Ophthalmic Drugs·119,871 affected·Oct 31, 2023
CriticalFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, ...
Ophthalmic Drugs·65,880 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Medical Implants·7,438 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Medical Implants·126 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Medical Implants·126 affected·Oct 31, 2023
High RiskFDA
Bioreference Health, Llc
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate spec...
Diagnostic Devices·1 affected·Oct 31, 2023
High RiskFDA
Zeus Scientific, Inc.
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Medical Devices·293 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Medical Implants·45 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Medical Implants·10,287 affected·Oct 31, 2023
RecallFDA
Grato Holdings, Inc.
V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 3...
Drugs·1,333 affected·Oct 30, 2023
CriticalFDA
Wanabana Usa Llc
Schnucks APPLE SAUCE FRUIT POUCH, CINNAMON Net Weight: 3.2 oz (90g) Pouches, 20 pack-3.2 oz poches per carton, 12 pack-3.2 oz poches per ...
Produce·2,998,088 affected·Oct 29, 2023
CriticalFDA
Wanabana Usa Llc
Weis CINNAMON APPLE SAUCE, Net Weight: 3.2 oz (90g) Pouches, 20 pack-3.2 oz poches per carton, NET WT 4LB carton, 12 pack 3.2 oz poches p...
Food·2,998,088 affected·Oct 29, 2023
CriticalFDA
Wanabana Usa Llc
WANABANA APPLE CINNAMON FRUIT PUREE, Net Weight: 2.50 oz (71g) Pouches, 15 poches per carton, 3-pack carton in one box.
Produce·2,998,088 affected·Oct 29, 2023
High RiskFDA
Pepsi Beverages, Llc
Crush Orange Soda, 24 Pack. 24 - 12 oz. cans. Caffeine Free. Contains No Juice. UPC 0 78000-01309 2. Produced under the Authority of...
Beverages·184 affected·Oct 27, 2023
RecallFDA
Ncs Healthcare Of Kentucky Inc
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx on...
Oral Drugs·12 affected·Oct 27, 2023
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC#...
Oral Drugs·9,263 affected·Oct 27, 2023
RecallFDA
Ncs Healthcare Of Kentucky Inc
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-3...
Drugs·1,344 affected·Oct 27, 2023
High RiskFDA
Vyaire Medical
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Respiratory Devices·16 affected·Oct 27, 2023
High RiskFDA
Limacorporate S.p.a
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Medical Devices·33 affected·Oct 27, 2023
RecallFDA
Vistapharm Llc
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC...
Oral Drugs·11,633 affected·Oct 26, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the deter...
Diagnostic Devices·6,035 affected·Oct 26, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the deter...
Diagnostic Devices·6,611 affected·Oct 26, 2023
RecallFDA
Wakefern Foods Corp.
Bowl & Basket Zero Calorie with Sucralose Sweetener 100 count, UPC 0-41190-06855-5, 12 retail cartons per wholesale case
Food·140 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator...
Medical Devices·291 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·264 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·451 affected·Oct 25, 2023
High RiskFDA
Riverpoint Medical, Llc
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF...
Medical Devices·999 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·47 affected·Oct 25, 2023
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Medical Devices·464 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·1,019 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·315 affected·Oct 25, 2023
High RiskFDA
Cardioquip, Llc
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Medical Devices·2 affected·Oct 24, 2023
High RiskFDA
Graphenano Dental Sl
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichrom...
Medical Devices·354 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Medical Devices·990 affected·Oct 24, 2023
High RiskFDA
Cardioquip, Llc
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Medical Devices·4 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, RE...
Medical Devices·4,878 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, ...
Medical Devices·4,470 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Medical Devices·1,127 affected·Oct 24, 2023
CriticalFDA
Gills Onions, Llc
Cross Valley Farms 4/5 LB CTN FRESH 1/8" SLIVERED YELLOW ONIONS W/ZIPPER
Produce·6,400 affected·Oct 23, 2023
CriticalFDA
Gills Onions, Llc
Gills Onions 4/5 LB CTN FRESH 3/8" DICED RED ONIONS WITH ZIPPER
Produce·1,600 affected·Oct 23, 2023
CriticalFDA
Gills Onions, Llc
Imperial Fresh 4/5 LB CTN FRESH 1/4" SLIVERED YLW ONIONS W/ZIP
Produce·4,900 affected·Oct 23, 2023
CriticalFDA
Gills Onions, Llc
Cross Valley Farms 1/5LB CTN FRESH 1/4" DICED RED ONIONS W/ZIP
Produce·325 affected·Oct 23, 2023
CriticalFDA
Gills Onions, Llc
Gills Onions 4/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER
Produce·4,620 affected·Oct 23, 2023
CriticalFDA
Gills Onions, Llc
Imperial Fresh 4/5LB CTN FRESH 1/8" SLIVERED YLW ONIONS W/ZIP
Produce·6,580 affected·Oct 23, 2023
CriticalFDA
Gills Onions, Llc
Cross Valley Farms 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
Produce·11,220 affected·Oct 23, 2023