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
Have an unsafe medication, device, or food to report?
Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.
How to report to FDA →68,659 recalls
CriticalFDA
Pharmedium Services, Llc
PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDiu...
Injectable Drugs24 affectedJan 28, 2015
CriticalFDA
Pharmedium Services, Llc
Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Ser...
Drugs20 affectedJan 28, 2015
CriticalFDA
Pharmedium Services, Llc
Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx ...
Injectable Drugs100 affectedJan 28, 2015
CriticalFDA
Lindt & Sprungli Usa
Lindt Chocolate Specialties Milk Chocolate Covered Almonds,6.4 oz. packaged in a stand up bag (resealable pouch) Item Number: #8698 (or...
Dairy19 affectedJan 27, 2015
CriticalFDA
The Lime Green Grocer, Inc.
Thai Delight Burrito, individually wrapped in clear plastic, keep refrigerated, serve hot or cold, Net wt. 11.5 oz (326g), UPC 7 94025 00...
Dairy783 affectedJan 27, 2015
CriticalFDA
Lindt & Sprungli Usa
Lindt Chocolate Specialties Milk Chocolate Covered Raisins,6.4 oz. packaged in a stand up bag (resealable pouch) Item Number: #8699 (or...
Dairy24 affectedJan 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Diagnostic Devices9,778 affectedJan 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
Diagnostic Devices1,719 affectedJan 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
Diagnostic Devices11,980 affectedJan 27, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ve...
Respiratory Devices3,213 affectedJan 27, 2015
High RiskFDA
Sazon, Inc.
Sazon without Annatto
Food156 affectedJan 26, 2015
CriticalFDA
Colonna Brothers Inc.
E & S Ground Cumin, Net Wt. 1 LB (16 oz.), E & S Foods, Inc., Whippany, NJ 07981, UPC 000000130059
Food2,729 affectedJan 26, 2015
High RiskFDA
Sazon, Inc.
Sazon with Saffron, Package Weights: 18 / 20 env 3.52 oz and 36 / 8 env 1.41 oz
Food11,125 affectedJan 26, 2015
High RiskFDA
Sazon, Inc.
Sazon Bohio with Coriander and Annatto
Food672 affectedJan 26, 2015
High RiskFDA
Sazon, Inc.
Sazon Coriander & Annatto
Food40,569 affectedJan 26, 2015
CriticalFDA
Colonna Brothers Inc.
Cremosa Ground Cumin, Net Wt. 1 LB (16 oz.), Dist. By Cremosa Food Company, LLC, 5 Park Drive, Melville, NY 11747
Food2,729 affectedJan 26, 2015
CriticalFDA
Colonna Brothers Inc.
Price Rite Ground Cumin, Net Wt. 3 oz, UPC 041190761135
Food2,729 affectedJan 26, 2015
High RiskFDA
Anazaohealth Corporation
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl ...
Injectable Drugs51 affectedJan 26, 2015
CriticalFDA
Coopersurgical, Inc.
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Dispos...
Medical Devices18,696,754 affectedJan 26, 2015
CriticalFDA
Coopersurgical, Inc.
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase ...
Surgical Devices20,398,889 affectedJan 26, 2015
High RiskFDA
Haemonetics Corporation
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the T...
Medical Devices4,143 affectedJan 26, 2015
CriticalFDA
Coopersurgical, Inc.
Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide ...
Medical Devices8,865,584 affectedJan 26, 2015
CriticalFDA
Wm. E. Martin & Sons Co., Inc.
CHILI POWDER 50 LBS
Food312 affectedJan 25, 2015
CriticalFDA
Julian Bakery, Inc.
Paleo Protein Bar Cookies N' Creme NET WT. 2.1OZ (60G) Manufactured by Julian Bakery, Inc. Developed by Paleo, Inc. GMO-Free, Glute...
Bakery & Grains116 affectedJan 25, 2015
CriticalFDA
Wm. E. Martin & Sons Co., Inc.
GROUND CUMIN STERILE TREATED PROD. OF TURKEY, 50 LBS.
Meat & Poultry396 affectedJan 25, 2015
CriticalFDA
Julian Bakery, Inc.
Paleo Protein Bar Chocolate Brownie NET WT. 2.1OZ (60G) GMO-Free, Gluten-Free, No Sugar Alcohols Ingredients: Egg (White Protein,...
Snacks & Candy405 affectedJan 25, 2015
CriticalFDA
Detox Transforms
AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00418 1.
Oral Drugs150 affectedJan 25, 2015
CriticalFDA
Detox Transforms
iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 ...
Oral Drugs200 affectedJan 25, 2015
CriticalFDA
Detox Transforms
EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529,...
Oral Drugs150 affectedJan 25, 2015
CriticalFDA
Detox Transforms
BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8.
Oral Drugs173 affectedJan 25, 2015
CriticalFDA
Detox Transforms
iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.
Oral Drugs175 affectedJan 25, 2015
CriticalFDA
Probar Llc
PROBAR Frosted Peanut Butter BASE Protein Bar, 2.46 oz film wrapped bar packaged in 12 wrapped units per sleeve/carton. Unit UPC:8-53152-...
Dairy180,682 affectedJan 23, 2015
CriticalFDA
Korean Food Co.
Go hyang Mak Kimchi 32 oz (UPC 042053138101) Product of U.S.A. TX. 972.790.4800 1311 Lukest, Irving, TX 75061; Go hyang Mak Kimchi 1/2 Ga...
Food5 affectedJan 23, 2015
CriticalFDA
Al's Picadera
LBL reads in part:*** AL'S PICADERA*** MANTENGASE REFRIGERADO ENTREMESES & POSTRES*** 3 LECHES***"
Food1,500 affectedJan 23, 2015
RecallFDA
Mylan Institutional Llc
Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutio...
Injectable Drugs78,090 affectedJan 23, 2015
High RiskFDA
Hospira Inc.
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- N...
Drugs4,339,500 affectedJan 23, 2015
High RiskFDA
Hospira Inc.
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- ...
Drugs13,720,475 affectedJan 23, 2015
High RiskFDA
Biologic Therapies, Inc
Bio-CORE Cannula (Needle) Set
Medical Devices0 affectedJan 23, 2015
High RiskFDA
Southern Implants, Inc
MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usa...
Medical Implants130 affectedJan 23, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Diagnostic Devices71 affectedJan 23, 2015
High RiskFDA
Biologic Therapies, Inc
Bio-PLASTY Cannula (Needle)
Medical Devices58 affectedJan 23, 2015
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the dir...
Medical Devices519 affectedJan 23, 2015
High RiskFDA
Chris A Papas & Son Co
Milk Opera Cream
Dairy20,304 affectedJan 22, 2015
High RiskFDA
Chris A Papas & Son Co
White Opera Cream
Dairy20,304 affectedJan 22, 2015
High RiskFDA
Chris A Papas & Son Co
Peanut Butter
Dairy4,968 affectedJan 22, 2015
High RiskFDA
Chris A Papas & Son Co
Coconut Easter Eggs
Food4,968 affectedJan 22, 2015
High RiskFDA
Chris A Papas & Son Co
Dark Chocolate Marshmallow Eggs
Snacks & Candy9,720 affectedJan 22, 2015
High RiskFDA
Chris A Papas & Son Co
Maple Nut
Food6,768 affectedJan 22, 2015