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
Greengate Fresh Lllp
GreenGate Fresh Standard Cello Spinach; 4 - 2.5lb plastic bags per box; SKU 465; Perishable hence require refrigeration at all times of i...
Produce·11 affected·Nov 10, 2023
High RiskFDA
Golden State Medical Supply Inc.
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bott...
Oral Drugs·1,941 affected·Nov 10, 2023
High RiskFDA
Golden State Medical Supply Inc.
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bott...
Oral Drugs·5,626 affected·Nov 10, 2023
RecallFDA
Fagron Compounding Services
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical O...
Injectable Drugs·756 affected·Nov 10, 2023
RecallFDA
Teva Pharmaceuticals Usa, Inc
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., Nor...
Topical Drugs·0 affected·Nov 10, 2023
High RiskFDA
Golden State Medical Supply Inc.
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufact...
Oral Drugs·2,502 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>...
Medical Devices·1,639 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents...
Medical Devices·4,182 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years)...
Medical Devices·126 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>...
Medical Devices·5,232 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 yea...
Medical Devices·8,294 affected·Nov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Medical Devices·31,685 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolesc...
Medical Devices·2,991 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents...
Medical Devices·3,354 affected·Nov 10, 2023
High RiskFDA
Encore Medical, Lp
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR K...
Surgical Devices·37 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12...
Medical Devices·1,796 affected·Nov 10, 2023
CriticalFDA
Freshpoint Of Southern Ca
Whole cantaloupe 3ct and 6ct brand name Imperial Fresh
Food·1,802 affected·Nov 9, 2023
CriticalFDA
Market Cuts Llc
Market Cuts 40 oz Combo Tray Fruit Small 40 Ounce tray UPC 092538001611; (No brand) 80 oz Combo Tray Fruit Large 80 Ounce tray UPC 092538...
Produce·122 affected·Nov 9, 2023
CriticalFDA
Market Cuts Llc
(No brand) 10 oz Mix Pico de Gallo w/Pineapple 3/8" 10 Ounce clamshell UPC 092538003233; Freshly Made Pico de Gallo w/Pineapple Mix 10 Ou...
Food·486 affected·Nov 9, 2023
CriticalFDA
Market Cuts Llc
Market Cuts 1 lb Pineapple Spear 1 Pound clamshell UPC 092538001239; Market Cuts 1 lb Pineapple Chunk 1"x1" 1 Pound clamshell UPC 092538...
Produce·6,873 affected·Nov 9, 2023
CriticalFDA
Market Cuts Llc
Little Salad Bar Cantaloupe Chunks, 1lb clamshell UPC 4099100215885; Market Cuts Cantaloupe Chunk 1" 1/5lb Tray, 5lb tray; Market Cuts1 l...
Produce·4,240 affected·Nov 9, 2023
CriticalFDA
Market Cuts Llc
Market Cuts 40 oz Combo Tray Fruit Small w/ Cream Cheese 40 Ounce tray UPC 092538002755; Market Cuts 80 oz Combo Tray Fruit Large w/ Crea...
Dairy·74 affected·Nov 9, 2023
High RiskFDA
Hans Kissle Company, Llc
Hans Kissle Potato Salad White Homestyle, 10 lb. bulk case, UPC Codes: 00036217701003
Produce·217 affected·Nov 9, 2023
CriticalFDA
Market Cuts Llc
Freshly Made Signature Melon 28oz bowl UPC 092538002274
Produce·8 affected·Nov 9, 2023
High RiskFDA
Jeni's Splendid Ice Creams Llc
Jeni's Splendid Ice Cream: Buttercream Birthday Cake Ice Cream packaged in paperboard pint cups with heat seals and paper lids - 8 pints ...
Dairy·58,473 affected·Nov 9, 2023
CriticalFDA
Market Cuts Llc
Market Cuts Fruit Mix Standard 1/5lb Tray 5 Pound tray; Market Cuts 1 lb Fruit Mix Chunk 1" 1 Pound clamshell UPC 092538000461; Market Cu...
Produce·434 affected·Nov 9, 2023
CriticalFDA
Market Cuts Llc
Freshly Made Signature Fruit 32oz bowl UPC 092538002298
Produce·8 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuti...
Injectable Drugs·5,948 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, N...
Injectable Drugs·2,458 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceutical...
Injectable Drugs·909 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Ra...
Injectable Drugs·400 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ...
Injectable Drugs·324 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pha...
Injectable Drugs·1,259 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceutic...
Injectable Drugs·1,023 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Ph...
Injectable Drugs·10,017 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 R...
Injectable Drugs·5,079 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Ra...
Injectable Drugs·548 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceu...
Injectable Drugs·500 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Wi...
Injectable Drugs·1,122 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow...
Drugs·1,425 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rai...
Injectable Drugs·9,624 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE...
Injectable Drugs·412 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Phar...
Injectable Drugs·2,427 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceutic...
Injectable Drugs·256 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Phar...
Injectable Drugs·3,671 affected·Nov 9, 2023