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
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How to report to FDA →68,659 recalls
High RiskFDA
Nomax Inc
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 600...
Ophthalmic Drugs15,444 affectedApr 19, 2024
High RiskFDA
Nomax Inc
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis,...
Ophthalmic Drugs6,960 affectedApr 19, 2024
High RiskFDA
Nomax Inc
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, I...
Ophthalmic Drugs4,648 affectedApr 19, 2024
High RiskFDA
Philips North America Llc
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Medical Devices358 affectedApr 19, 2024
RecallFDA
Tiffany Food Corp.
Sweet Preserved Dried Plums; Farmer's Grange; Series Food; 88g; Plastic synthetic (flexible) package; INGREDIENTS: Plum, Salt, Sugar, ADD...
Food22 affectedApr 18, 2024
High RiskFDA
Bf Suma Pharmaceuticals, Inc.
Longreen Corporation Xlim Express Coffee, 15 grams/sachet, 10 sachets/box
Beverages23,701 affectedApr 18, 2024
High RiskFDA
Black Forge Knives
1- Name: Carbon Steel Utility Kitchen Knife Model: CSK1700 Size: Total length: 10.25" Type of packaging: Each knife packed ...
Meat & Poultry21,000 affectedApr 18, 2024
High RiskFDA
Bf Suma Pharmaceuticals, Inc.
Longreen Corporation 4 in1 Reishi Coffee, 18.2 grams/sachet, 10 sachets/box
Beverages59,873 affectedApr 18, 2024
High RiskFDA
Mucci Food Products, Ltd. Dba Mama Mucci's Pasta
Mucci Food Products, Ltd. Tiramisu Italian Dessert, 2, 4.25 lb trays per case
Food50 affectedApr 18, 2024
CriticalFDA
Graceleigh, Inc. Dba Sammy's Milk
Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak
Dairy2,487 affectedApr 18, 2024
CriticalFDA
Graceleigh, Inc. Dba Sammy's Milk
Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch
Dairy1,465 affectedApr 18, 2024
High RiskFDA
Stryker Neurovascular
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The ...
Surgical Devices373,246 affectedApr 18, 2024
High RiskFDA
Bd Switzerland Sarl
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery o...
Medical Devices11 affectedApr 18, 2024
CriticalFDA
Optumhealth Care Solutions Llc
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Medical Devices208 affectedApr 18, 2024
High RiskFDA
Exactech, Inc.
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Medical Devices0 affectedApr 18, 2024
High RiskFDA
Exactech, Inc.
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 2...
Medical Devices0 affectedApr 18, 2024
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Diagnostic Devices116 affectedApr 18, 2024
High RiskFDA
Stryker Neurovascular
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped version...
Surgical Devices41,074 affectedApr 18, 2024
High RiskFDA
Stryker Neurovascular
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0...
Surgical Devices105,286 affectedApr 18, 2024
High RiskFDA
Sacramento Cookie Factory
California Wine Wafer - Mocha Chocolate and Original Wine Wafer - Mocha Chocolate [Two sizes: retail package of 8 wafers (7 oz) and retai...
Snacks & Candy8 affectedApr 17, 2024
High RiskFDA
Sacramento Cookie Factory
Champagne Wafer - Raspberry Almond [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
Produce8 affectedApr 17, 2024
High RiskFDA
Sacramento Cookie Factory
Java Wafer - Mocha Hazelnut [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
Food8 affectedApr 17, 2024
High RiskFDA
Sacramento Cookie Factory
Original Wine Wafer - Lemon Vanilla [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
Food8 affectedApr 17, 2024
High RiskFDA
Sacramento Cookie Factory
Tea Wafer - Vanilla Almond [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
Beverages8 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Ro...
Drugs3,504 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tu...
Drugs2,864 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle wi...
Topical Drugs500 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 12...
Topical Drugs192 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT...
Topical Drugs1,680 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113...
Topical Drugs3,000 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bo...
Drugs3,440 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum...
Topical Drugs4,013 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sp...
Topical Drugs6,264 affectedApr 17, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Gl...
Oral Drugs3,264 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tu...
Drugs7,410 affectedApr 17, 2024
High RiskFDA
Arg Laboratories, Inc.
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW ...
Drugs9,697 affectedApr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Blood Pump Rotor, Model Number: F40015481 Rev A
Medical Devices45,880 affectedApr 17, 2024
High RiskFDA
Nrt X-ray A/s
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Medical Devices35 affectedApr 17, 2024
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Medical Devices1,822 affectedApr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices12,292 affectedApr 17, 2024
High RiskFDA
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Surgical Devices5,604 affectedApr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices334 affectedApr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices931 affectedApr 17, 2024
High RiskFDA
Cardinal Health 200, Llc
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
Medical Devices2,000 affectedApr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Medical Devices11,371 affectedApr 17, 2024
High RiskFDA
La Original Tortilla Co., Inc.
Bulk flour tortillas sold to food service. 20ct 6in flour. 12 packages of 20ct per case. Packed in clear plastic bag and cardboard box.
Food35 affectedApr 16, 2024
High RiskFDA
S Martinelli & Company
Martinelli's Gold Medal Apple Juice From U.S. Grown Fresh Apples 1 Liter (33.8 fl oz.) No Additives of Any Kind UPC 0 00 41244 00102 6
Beverages24,519 affectedApr 16, 2024
CriticalFDA
Infinite Herbs, Llc
Infinite Herbs Organic Basil packed in a clear 2.5 oz, 2.0 oz, and 4 oz PET clamshell container.
Food235,077 affectedApr 16, 2024