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
RecallFDA
Taro Pharmaceuticals Inc.
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontari...
Drugs·11,196 affected·Nov 6, 2023
CriticalFDA
Bayer Healthcare Pharmaceuticals Inc.
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany...
Oral Drugs·192 affected·Nov 6, 2023
High RiskFDA
Merit Medical Systems, Inc.
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC21...
Surgical Devices·717 affected·Nov 6, 2023
High RiskFDA
Sarnova Hc, Llc
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professional...
Medical Devices·15 affected·Nov 6, 2023
High RiskFDA
Physio-control, Inc.
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Cardiac Devices·18,732 affected·Nov 6, 2023
High RiskFDA
Merit Medical Systems, Inc.
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Surgical Devices·59 affected·Nov 6, 2023
High RiskFDA
Maquet Medical Systems Usa
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorpore...
Cardiac Devices·1,595 affected·Nov 6, 2023
CriticalFDA
Nurse Assist, Llc
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203...
Medical Devices·61,740 affected·Nov 6, 2023
High RiskFDA
The Coastal Companies Dba Hearn Kirkwood
Le Croissant Turkey & Cheddar Net Wt. 5.5oz (156g) UPC:766375261629 Packaged in clamshell container. Sold as single unit and 6-unit pack ...
Meat & Poultry·238 affected·Nov 3, 2023
High RiskFDA
California Bread Co.
California Baking Company Telera Bread (La Torta Bread), 6 pack (26 oz) and 12 pack (58 oz), plastic bags
Bakery & Grains·8,959 affected·Nov 3, 2023
High RiskFDA
The Coastal Companies Dba Hearn Kirkwood
Breakfast Sandwich Bacon Egg & Cheddar Croissant Net Wt. 5.25oz (149g) UPC:766375253051. Packaged in clamshell container. Sold as single ...
Food·1,141 affected·Nov 3, 2023
High RiskFDA
Doctors Scienfic Organica
Burn Boot Camp AFTERBURN GRASS-FED WHEY PROTEN BAR, TRIPLE CHOCOLATE WITH ALMOND BUTTER, NET WT. 2.12 OZ (60 G), packaged in metalized film.
Dairy·66,960 affected·Nov 3, 2023
CriticalFDA
The Coastal Companies Dba Hearn Kirkwood
Le Croissant Tuna Salad Net Wt. 5.8oz (164g) UPC:766375261605 Packaged in clamshell container. Sold under Food Unlimited brand. Sold as s...
Seafood·262 affected·Nov 3, 2023
CriticalFDA
The Coastal Companies Dba Hearn Kirkwood
Le Croissant Chicken Salad Net Wt. 5.8oz (164g) UPCs:766375795018, 766375797128, 766375261599, 766375261599 Packaged in clamshell contain...
Meat & Poultry·4,146 affected·Nov 3, 2023
High RiskFDA
The Coastal Companies Dba Hearn Kirkwood
Le Croissant Ham & Swiss Net Wt. 5.5oz (156g) UPC:766375261612 Packaged in clamshell container. Sold under Food Unlimited brand.
Food·108 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Medical Devices·553 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Medical Devices·941 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE PVP SOLUTION, REF DYNDA1907
Medical Devices·8,250 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE POVIDONE, REF DYNDA2061
Medical Devices·300 affected·Nov 3, 2023
High RiskFDA
Medtronic Inc.
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Cardiac Devices·64,739 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Medical Devices·157 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE BETADINE, REF DYNDA1998
Medical Devices·1,800 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Medical Devices·731 affected·Nov 3, 2023
High RiskFDA
Liberty Medical Solutions, Llc
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Medical Devices·473 affected·Nov 3, 2023
High RiskFDA
Inpeco S.a.
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analyt...
Medical Devices·1 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
Medical Devices·888 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Medical Devices·111 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE PVP, REF DYNDA1649
Medical Devices·700 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE STERILE PREP STICK, REF DYNDA1134
Medical Devices·240 affected·Nov 3, 2023
High RiskFDA
Scoular Grain Co
Milled Brown Flax - MBF9, 50lb bag
Food·40,000 affected·Nov 2, 2023
High RiskFDA
Scoular Grain Co
Milled Golden Flax MGDF, 50 lb bag
Food·10,000 affected·Nov 2, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)100...
Oral Drugs·25,776 affected·Nov 1, 2023
High RiskFDA
Padagis Us Llc
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. L...
Oral Drugs·7,032 affected·Nov 1, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c...
Oral Drugs·34,392 affected·Nov 1, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 M...
Oral Drugs·48,623 affected·Nov 1, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario...
Oral Drugs·4,074 affected·Nov 1, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Medical Devices·835 affected·Nov 1, 2023
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Medical Devices·454 affected·Nov 1, 2023
CriticalFDA
B. Braun Medical, Inc.
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/...
Medical Devices·33,820,976 affected·Nov 1, 2023
High RiskFDA
Medline Industries, Lp - Northfield
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
Medical Devices·4,850 affected·Nov 1, 2023
High RiskFDA
Medline Industries, Lp - Northfield
PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
Medical Devices·1,770 affected·Nov 1, 2023
High RiskFDA
Medline Industries, Lp - Northfield
BLOOD CULTURE KIT, REF DYNDH1647B
Medical Devices·1,890 affected·Nov 1, 2023
High RiskFDA
Turncare, Inc
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
Medical Devices·1,081 affected·Nov 1, 2023
RecallFDA
Bisousweet Confections
Bisousweet Confections Chocolate Whoopie Pies
Snacks & Candy·124 affected·Oct 31, 2023
High RiskFDA
Abbott Laboratories
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Food·226,650 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distribut...
Drugs·11,782 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropp...
Drugs·11,629 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distribute...
Ophthalmic Drugs·28,477 affected·Oct 31, 2023