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
B. Braun Medical Inc
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical In...
Injectable Drugs·1,380 affected·May 9, 2023
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1...
Drugs·3,232 affected·May 9, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, I...
Oral Drugs·5,344 affected·May 9, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the foll...
Respiratory Devices·368 affected·May 9, 2023
High RiskFDA
Virtual Radiologic Corp.
vRad PACS with Mammography
Medical Devices·8 affected·May 9, 2023
High RiskFDA
Sodexo Operations, Llc
simply to go Strawberry Yogurt Parfaits, 8.53oz, UPC 477088125794; packaged in plastic cups
Dairy·50,343 affected·May 8, 2023
High RiskFDA
Sodexo Operations, Llc
simply to go Blueberry Yogurt Parfaits, 8.53oz, UPC 477088156552 and 477088150550; packaged in plastic cups
Dairy·23,059 affected·May 8, 2023
RecallFDA
Amneal Pharmaceuticals Of New York, Llc
Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for ...
Injectable Drugs·69,239 affected·May 8, 2023
High RiskFDA
Galt Medical Corporation
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Medical Devices·490 affected·May 8, 2023
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Cardiac Devices·1,147 affected·May 8, 2023
High RiskFDA
Galt Medical Corporation
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07...
Medical Devices·6,036 affected·May 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Respiratory Devices·705 affected·May 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Medical Devices·24 affected·May 8, 2023
High RiskFDA
Meijer Inc
Meijer Sweet & Salty Trail Mix 12oz. pouch, UPC 7 08820 10371 9
Food·1,824 affected·May 6, 2023
CriticalFDA
Chang & Son Enterprises, Inc.
Nature's Wonder Premium Soybean Sprouts 12oz bag (UPC: 815098001347)
Food·29,340 affected·May 5, 2023
CriticalFDA
Chang & Son Enterprises, Inc.
a.) BEAN SPROUTS, 10 LBS, PRODUCT OF USA; CHANG FARM; SO.DEERFIELD, MA; KEEP REFRIGERATED; package in plastic bags b.) Nature's Wonder b...
Food·748,920 affected·May 5, 2023
RecallFDA
Jost Chemical Co
Jost Chemical Magnesium Citrate Tribasic Hydrate, USP, Powder, Net Wt 110 lb/ 50 kg packaged in bulk lined fiber drums
Food·73 affected·May 5, 2023
CriticalFDA
Lancaster Foods Llc
GIANT CURLY LEAF SPINACH, 12 /8 OZ, UPC: 6-88267-09813-0. Packaged in sealed plastic bags, 12 in a case.
Produce·486 affected·May 5, 2023
CriticalFDA
Lancaster Foods Llc
LANCASTER SPINACH, 10 OZ, UPC:8-13055-01145-3. Packaged in sealed plastic bags, 12 in a case.
Produce·25 affected·May 5, 2023
CriticalFDA
Lancaster Foods Llc
ROBINSON FRESH COLLARD GREENS, 16 OZ, UPC:0-95829-60006-7. Packaged in sealed plastic bags, 8 in a case. GIANT COLLARD GREENS, 16 OZ, UP...
Food·1,221 affected·May 5, 2023
High RiskFDA
Origami Catering, Llc
Multigrain Spicy Salmon Avocado Roll, net wt. 7 oz., Ready to Eat, perishable and refrigerated product. UPC 8 51016 00244 7. Manufactured...
Seafood·89 affected·May 5, 2023
CriticalFDA
Lancaster Foods Llc
ROBINSON FRESH KALE GREENS, NET WT 16 OZ, UPC:0-95829-60015. Packaged in sealed plastic bags, 8 in a case. ROBINSON FRESH KALE GREENS N...
Food·2,564 affected·May 5, 2023
High RiskFDA
Elekta, Inc.
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Medical Devices·46 affected·May 5, 2023
CriticalFDA
Frito-lay, Inc. Headquarters
Lay s Classic Party Size Potato Chips 13 oz. (368.5 g) UPC 028400310413 packaged in a yellow flexible bag and Lay s Classic Mix and Match...
Snacks & Candy·200 affected·May 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon d...
Medical Devices·0 affected·May 4, 2023
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of a...
Diagnostic Devices·1 affected·May 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon di...
Medical Devices·0 affected·May 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disru...
Medical Implants·0 affected·May 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon d...
Medical Devices·0 affected·May 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Medical Devices·340 affected·May 4, 2023
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducib...
Diagnostic Devices·30 affected·May 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disru...
Medical Implants·0 affected·May 4, 2023
RecallFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Medical Devices·4 affected·May 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Medical Devices·45 affected·May 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
Medical Devices·13,707 affected·May 4, 2023
CriticalFDA
Hms Host International Inc
Ultra Tuna Salad Sandwich, brand DishD'Lish. The label declares Albacore Tuna with Fresh Herbs, Mayo, Capers, Cucumbers, and pickles on ...
Seafood·46 affected·May 3, 2023
CriticalFDA
Hms Host International Inc
Ultra Tuna Salad Cup, brand DishD'Lish, packaged in plastic cup. Label declares Housemade Albacore Tuna Salad, Arugula, Cucumber and Ch...
Seafood·19 affected·May 3, 2023
High RiskFDA
Avery Brewing Company
Gose con Sandia, Sour Ale with watermelon, limes and sea salt, 12 oz. Can 6 pk. (72 oz. total) Can UPC 7 96363 00495 2, Carton UPC 7 ...
Beverages·1,078 affected·May 3, 2023
CriticalFDA
Hms Host International Inc
House Made Tarragon Chicken Salad Sandwich, brand DishD'Lish. The label declares House Roasted Chicken Breast, Herbs, Fresh Tarragon, Ar...
Meat & Poultry·57 affected·May 3, 2023
CriticalFDA
Kenover Marketing Corp.
Mighty Sesame 10.9 Oz Organic Tahini (Squeezable) bottle, UPC 858313006208, 8 Units per case.
Food·1,447 affected·May 3, 2023
High RiskFDA
Denison Pharmaceuticals, Llc
Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 St...
Drugs·4,812 affected·May 3, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Oral Drugs·12,336 affected·May 3, 2023
High RiskFDA
Denison Pharmaceuticals, Llc
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Krame...
Drugs·13,968 affected·May 3, 2023
High RiskFDA
Denison Pharmaceuticals, Llc
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sa...
Drugs·54,222 affected·May 3, 2023
High RiskFDA
Denison Pharmaceuticals, Llc
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laborato...
Drugs·86,616 affected·May 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Medical Devices·851,328 affected·May 3, 2023
High RiskFDA
Bolton Medical Inc.
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extens...
Medical Implants·216 affected·May 3, 2023
CriticalFDA
Noxbox Ltd
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Medical Devices·548 affected·May 3, 2023