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
www.fda.gov →Official Site

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
RecallFDA
Hi-tech Pharmaceuticals Inc.
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT WATERMELON NATURALL...
Beverages·85,950 affected·Aug 6, 2025
RecallFDA
Hi-tech Pharmaceuticals Inc.
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT KIWI-STRAWBERRY NAT...
Produce·85,950 affected·Aug 6, 2025
High RiskFDA
The Candy Barn
Peanut Butter Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
Dairy·665 affected·Aug 6, 2025
RecallFDA
Hi-tech Pharmaceuticals Inc.
LGSCIENCES BATTLE HARDENER PLATINUM SERIES COMPLETE 6 WEEK CYCLE WITH PCT LEGAL GEAR DIETARY SUPPLEMENT 17-PROANDRO pBOLD FORM-XT UPC 7 4...
Supplements·85,950 affected·Aug 6, 2025
High RiskFDA
The Candy Barn
Chocolate Walnut Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
Snacks & Candy·665 affected·Aug 6, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pha...
Oral Drugs·14,976 affected·Aug 6, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, P...
Oral Drugs·17 affected·Aug 6, 2025
High RiskFDA
Westminster Pharmaceuticals Llc
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapu...
Oral Drugs·4,456 affected·Aug 6, 2025
High RiskFDA
Westminster Pharmaceuticals Llc
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur...
Oral Drugs·16,672 affected·Aug 6, 2025
CriticalFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Cardiac Devices·41,200 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Medical Devices·29,811 affected·Aug 6, 2025
High RiskFDA
Maquet Cardiovascular, Llc
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) S...
Medical Devices·98 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code...
Medical Devices·987,911 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and fem...
Medical Devices·15,546 affected·Aug 6, 2025
CriticalFDA
Olympus Corporation Of The Americas
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of fou...
Medical Devices·104,508 affected·Aug 6, 2025
High RiskFDA
Seaspine Orthopedics Corporation
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Medical Devices·74 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Medical Devices·265,500 affected·Aug 6, 2025
CriticalFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Cardiac Devices·25,261 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code...
Medical Devices·211,750 affected·Aug 6, 2025
High RiskFDA
M.o.m Enterprises, Llc.
Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitam...
Produce·85,248 affected·Aug 5, 2025
High RiskFDA
Kobayashi Noodle U.s.a.
Product is distributed in 10lb bulk packaging. Brown cardboard box with generic label. Raw Ramen Noodle HA #22W (16049) UPC: NONE Manufac...
Food·945 affected·Aug 5, 2025
High RiskFDA
Khee Trading, Inc.
Product is Frozen Half Shell Oysters in 15 pound blacks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER ...
Seafood·828 affected·Aug 5, 2025
High RiskFDA
Kobayashi Noodle U.s.a.
Product is distributed in 10lb bulk packaging. Brown cardboard box with generic label. Raw Ramen Noodle HA #22W (4942) UPC: NONE Manufact...
Food·2,800 affected·Aug 5, 2025
High RiskFDA
Khee Trading, Inc.
Product is Frozen Half Shell Oysters in 15 pound blacks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER ...
Seafood·98 affected·Aug 5, 2025
RecallFDA
Haleon Us Holdings Llc
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (...
Drugs·46,692 affected·Aug 5, 2025
High RiskFDA
Cardinal Health Inc.
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, R...
Injectable Drugs·10 affected·Aug 5, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124...
Oral Drugs·11,328 affected·Aug 5, 2025
High RiskFDA
Boston Scientific Corporation
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Medical Devices·458 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active L...
Medical Devices·15,441 affected·Aug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices·25,778 affected·Aug 5, 2025
High RiskFDA
Tandem Diabetes Care, Inc.
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide whe...
Diabetes Devices·122,958 affected·Aug 5, 2025
High RiskFDA
Philips Medical Systems (cleveland) Inc
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18...
Medical Devices·810 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural ...
Medical Devices·111,492 affected·Aug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices·330 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Descriptio...
Medical Devices·994 affected·Aug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices·6 affected·Aug 5, 2025
High RiskFDA
Boston Scientific Corporation
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5....
Medical Devices·1,369 affected·Aug 5, 2025
CriticalFDA
Neuhaus Nv
NEUHAUS brand ORIGINAL BELGIAN CHOCOLATE; POPPING MILK CHOCOLATES WITH COOKIES; 4.23 oz - 120g; (EN)Chocolates - INGREDIENTS: milk chocol...
Dairy·100 affected·Aug 4, 2025
High RiskFDA
Hans Kissle Company, Llc
Hans Kissle Red Bliss Potato Salad
Produce·66 affected·Aug 4, 2025
High RiskFDA
B Braun Medical Inc
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medic...
Injectable Drugs·23,100 affected·Aug 4, 2025
High RiskFDA
B Braun Medical Inc
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical ...
Injectable Drugs·74,088 affected·Aug 4, 2025
High RiskFDA
Pfizer Inc
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409...
Injectable Drugs·49,620 affected·Aug 4, 2025
High RiskFDA
Pfizer Inc
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-...
Injectable Drugs·15,750 affected·Aug 4, 2025
High RiskFDA
Wasatch Photonics
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER...
Medical Devices·192 affected·Aug 4, 2025
CriticalFDA
Baxter Healthcare Corporation
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Medical Devices·10,101 affected·Aug 4, 2025
High RiskFDA
Avid Medical, Inc.
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Medical Devices·57 affected·Aug 4, 2025
CriticalFDA
Baxter Healthcare Corporation
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Medical Devices·43,922 affected·Aug 4, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i C...
Medical Devices·116 affected·Aug 4, 2025