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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
Coloplast Manufacturing Us, Llc
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
Medical Implants·13 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Medical Implants·11 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
Medical Implants·20 affected·Mar 1, 2023
High RiskFDA
Covidien, Lp
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Medical Devices·770 affected·Mar 1, 2023
High RiskFDA
Atrium Medical Corporation
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
Medical Devices·8,184 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
Medical Implants·1 affected·Mar 1, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Medical Devices·1,730 affected·Mar 1, 2023
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number:...
Medical Devices·47 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
Medical Implants·15 affected·Mar 1, 2023
High RiskFDA
Stryker Sustainability Solutions
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30...
Medical Devices·127,894 affected·Mar 1, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Respiratory Devices·4,940 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Medical Implants·2 affected·Mar 1, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Respiratory Devices·1,412 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
Medical Implants·20 affected·Mar 1, 2023
High RiskFDA
Covidien, Lp
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V2...
Medical Devices·36,204 affected·Mar 1, 2023
High RiskFDA
Russell Stover Candies Inc
Russel Stover Sugar Free Peanut Butter Cups packaged in 2.4oz peg bag, containing individually wrapped pieces. UPC 077260096937
Dairy·22,682 affected·Feb 28, 2023
High RiskFDA
4 J's Treats, Llc Dba Bruttles Gourmet Candies
Butter Toffee, net wt. 16 oz, 6 units per case. Label declares: Butter Toffee, Butter, Sugar, Corn Syrup, Almonds, Vanilla, Salt. www.bru...
Dairy·25 affected·Feb 28, 2023
High RiskFDA
Ba Sports Nutrition, Llc
BODYARMOR SportWater 24/700mL; BODYARMOR SportWater 12/1Liter; BODYARMOR SportWater 24/20oz 6PK; BODYARMOR SportWater 2x6/1 Liter; BODYAR...
Beverages·21,000,000 affected·Feb 28, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. fo...
Injectable Drugs·28,875 affected·Feb 28, 2023
High RiskFDA
Omega Medical Imaging, Inc.
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Medical Devices·52 affected·Feb 28, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Medical Devices·391 affected·Feb 28, 2023
High RiskFDA
Insulet Corporation
Omnipod 5 Automated Insulin Delivery System
Diabetes Devices·11,016 affected·Feb 28, 2023
High RiskFDA
Elekta Inc
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·2,020 affected·Feb 28, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 099...
Medical Devices·391 affected·Feb 28, 2023
High RiskFDA
Bio-rad Laboratories, Inc.
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Diagnostic Devices·932 affected·Feb 28, 2023
CriticalFDA
Lidl Us Trading
Tapas Cocktail White Tiger Shrimp Net Wt 7oz (198g) UPC:4056489411499 Packaged in a plastic container.
Seafood·17,136 affected·Feb 27, 2023
CriticalFDA
Jan Fruits, Inc.
Enoki Mushrooms 200g 50 units per box UPC: 851084 008358 Lot #3779 on outside of box Imported from Taiwan Distributor: Jan Fruits, Inc. 4...
Produce·310 affected·Feb 24, 2023
High RiskFDA
Kawasho Foods Usa, Inc
Geisha Medium Shrimp; WT 4OZ(113g)
Seafood·1,629 affected·Feb 24, 2023
High RiskFDA
Ecometics, Inc.
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packag...
Topical Drugs·0 affected·Feb 24, 2023
High RiskFDA
Ecometics, Inc.
Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by...
Drugs·18,000 affected·Feb 24, 2023
RecallFDA
Zydus Pharmaceuticals (usa) Inc
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manuf...
Oral Drugs·21,936 affected·Feb 24, 2023
High RiskFDA
Ecometics, Inc.
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct ...
Oral Drugs·34,320 affected·Feb 24, 2023
High RiskFDA
Ecometics, Inc.
Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854
Drugs·4,210 affected·Feb 24, 2023
High RiskFDA
Ecometics, Inc.
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Dis...
Topical Drugs·20,746 affected·Feb 24, 2023
CriticalFDA
Global Pharma Healthcare Private Limited
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma ...
Topical Drugs·50,000 affected·Feb 24, 2023
High RiskFDA
Ecometics, Inc.
Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
Drugs·23,993 affected·Feb 24, 2023
RecallFDA
Sca Pharmaceuticals
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Conta...
Injectable Drugs·2,125 affected·Feb 24, 2023
High RiskFDA
Ecometics, Inc.
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Compan...
Topical Drugs·37,968 affected·Feb 24, 2023
High RiskFDA
Tobii Dynavox Llc
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 75...
Medical Devices·3,924 affected·Feb 24, 2023
High RiskFDA
Lemonland Food Corp
Seasoned Dried Pollack distributed in un-labeled plastic containers 6oz., 8 oz., and 12 oz. Containers were then labeled at H-mart, G-ma...
Food·6 affected·Feb 23, 2023
High RiskFDA
Lemonland Food Corp
Stir-Fried Kimchi distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
Food·12 affected·Feb 23, 2023
High RiskFDA
Lemonland Food Corp
Seasoned Pickled Radish distributed in un-labeled plastic containers 6oz, 8oz, 12oz, and 16oz. Containers were then labeled at H-mart, G...
Food·6 affected·Feb 23, 2023
High RiskFDA
Lemonland Food Corp
Hot Pepper in Soy Sauce distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail ...
Food·12 affected·Feb 23, 2023
High RiskFDA
Lemonland Food Corp
Wild Leek distributed in un-labeled plastic containers 8oz and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
Food·8 affected·Feb 23, 2023
High RiskFDA
Lemonland Food Corp
Stir-Fried Fish Cake distributed in un-labeled plastic containers 6oz, 8oz, 12oz, and 16oz. Containers were then labeled at H-mart, G-ma...
Seafood·6 affected·Feb 23, 2023
High RiskFDA
Lemonland Food Corp
Seasoned Peanut distributed in un-labeled plastic containers 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
Food·8 affected·Feb 23, 2023
High RiskFDA
Lemonland Food Corp
Seasoned Fish Meat distributed in un-labeled plastic containers 8oz. and 12oz. Containers were then labeled at H-mart, G-mart, or M2M re...
Meat & Poultry·8 affected·Feb 23, 2023
High RiskFDA
Lemonland Food Corp
Seasoned Radish Sliced distributed in un-labeled plastic containers 6oz., 8 oz., and 12 oz. Containers were then labeled at H-mart, G-ma...
Food·6 affected·Feb 23, 2023