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
High RiskFDA
Nutrition Corp
Fresh N Lean brand Crustless Chicken Potato Pot Pie. Packaged in plastic trays, vacuum sealed.
Meat & Poultry·2,119 affected·Apr 25, 2024
High RiskFDA
Wegmans Food Markets, Inc.
Wegman's Half Loaf Garlic Bread
Bakery & Grains·11,017 affected·Apr 25, 2024
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), R...
Ophthalmic Drugs·382,104 affected·Apr 25, 2024
High RiskFDA
Sagent Pharmaceuticals
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAG...
Injectable Drugs·14,360 affected·Apr 25, 2024
Medium RiskFDA
Viatris Inc
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0...
Oral Drugs·143,230 affected·Apr 25, 2024
High RiskFDA
Covidien, Llc
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Surgical Devices·0 affected·Apr 25, 2024
High RiskFDA
Synthes (usa) Products Llc
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic s...
Medical Implants·261 affected·Apr 25, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, ...
Oral Drugs·17,070 affected·Apr 24, 2024
High RiskFDA
Somerset Therapeutics Llc
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70...
Injectable Drugs·5,578 affected·Apr 24, 2024
High RiskFDA
Aurobindo Pharma Usa Inc.
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, R...
Oral Drugs·6,909 affected·Apr 24, 2024
High RiskFDA
Aurobindo Pharma Usa Inc.
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, R...
Oral Drugs·6,696 affected·Apr 24, 2024
RecallFDA
Acella Pharmaceuticals, Llc
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA ...
Drugs·7,104 affected·Apr 24, 2024
High RiskFDA
Coast Quality Pharmacy, Llc Dba Anazao Health
Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd...
Oral Drugs·9,896 affected·Apr 24, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, ...
Oral Drugs·17,040 affected·Apr 24, 2024
High RiskFDA
Lucid Diagnostics, Inc.
Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Pr...
Medical Devices·220 affected·Apr 24, 2024
High RiskFDA
Barco N.v.
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
Medical Devices·88 affected·Apr 24, 2024
High RiskFDA
Lucid Diagnostics, Inc.
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Pr...
Medical Devices·157 affected·Apr 24, 2024
High RiskFDA
Smith & Nephew Inc
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Medical Devices·23 affected·Apr 24, 2024
High RiskFDA
Olympus Corporation Of The Americas
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user in...
Surgical Devices·227 affected·Apr 24, 2024
High RiskFDA
Epi Health, Llc
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, I...
Oral Drugs·5,664 affected·Apr 23, 2024
High RiskFDA
Epi Health, Llc
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC...
Topical Drugs·18,645 affected·Apr 23, 2024
High RiskFDA
Regeneron Pharmaceuticals Inc
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron ...
Injectable Drugs·251,504 affected·Apr 23, 2024
High RiskFDA
Epi Health, Llc
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, I...
Oral Drugs·12,808 affected·Apr 23, 2024
High RiskFDA
Stryker Neurovascular
Trevo ProVue, Catalog: 90184
Medical Devices·280 affected·Apr 23, 2024
High RiskFDA
Stryker Neurovascular
Trevo Trak 21 Microcatheter, Catalog: 90338
Surgical Devices·899 affected·Apr 23, 2024
High RiskFDA
Cadwell Industries Inc
Cascade IOMAX Cortical Module, REF: 190296-200
Medical Devices·54 affected·Apr 23, 2024
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Card...
Medical Devices·5 affected·Apr 23, 2024
High RiskFDA
Stryker Neurovascular
Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOF...
Medical Devices·2,859 affected·Apr 23, 2024
High RiskFDA
Stryker Neurovascular
DAC 044 115cm, Catalog: 90760
Medical Devices·81 affected·Apr 23, 2024
RecallFDA
Sun Pharmaceutical Industries Inc
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., In...
Ophthalmic Drugs·35,069 affected·Apr 22, 2024
CriticalFDA
Stop Clopez Corp
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
Oral Drugs·5 affected·Apr 22, 2024
CriticalFDA
Philips North America Llc
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnost...
Diagnostic Devices·32 affected·Apr 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
Medical Devices·5,075,234 affected·Apr 22, 2024
High RiskFDA
Wondfo Usa Co Ltd
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Diagnostic Devices·1,238,755 affected·Apr 22, 2024
High RiskFDA
Alcon Research Llc
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalm...
Medical Devices·4,930 affected·Apr 22, 2024
High RiskFDA
Alcon Research Llc
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Medical Devices·29,190 affected·Apr 22, 2024
High RiskFDA
Wondfo Usa Co Ltd
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b...
Diagnostic Devices·170,000 affected·Apr 22, 2024
High RiskFDA
Wondfo Usa Co Ltd
Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta On...
Diagnostic Devices·75,000 affected·Apr 22, 2024
High RiskFDA
Alcon Research Llc
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalm...
Medical Devices·19,867 affected·Apr 22, 2024
CriticalFDA
Philips North America Llc
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagno...
Diagnostic Devices·19 affected·Apr 22, 2024
High RiskFDA
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Diagnostic Devices·1,275 affected·Apr 22, 2024
High RiskFDA
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Diagnostic Devices·1,275 affected·Apr 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
Medical Devices·25,214,334 affected·Apr 22, 2024
High RiskFDA
Wondfo Usa Co Ltd
Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wond...
Diagnostic Devices·0 affected·Apr 22, 2024
CriticalFDA
Revive Rx Llc Dba Revive Rx Pharmacy
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf ...
Drugs·751 affected·Apr 20, 2024
High RiskFDA
Kraft Heinz Foods Company
Primal Kitchen Avocado Oil 1PT 9.3 FL OZ (750ml) glass bottle UPC 855232007194, 6 bottles per wholesale case
Food·2,061 affected·Apr 19, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manuf...
Injectable Drugs·11,016 affected·Apr 19, 2024
High RiskFDA
Nomax Inc
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 str...
Ophthalmic Drugs·15,056 affected·Apr 19, 2024