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
High RiskFDA
Howmedica Osteonics Corp.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Medical Devices·0 affected·Oct 15, 2021
High RiskFDA
The Binding Site Group, Ltd.
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK...
Medical Devices·2,254 affected·Oct 15, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Medical Implants·2 affected·Oct 15, 2021
High RiskFDA
Keurig Dr Pepper
Target Good & Gather Coconut Pineapple Sparkling Water 8 pack of 12 oz. cans UPC can: 0 85239 04059 1, UPC outer carton (8 pack): 0 85239...
Beverages·2,148 affected·Oct 14, 2021
High RiskFDA
Keurig Dr Pepper
7UP Zero Sugar Lemon Lime Soda 12 pack of 12 oz. can UPC Cardboard Wrap Code: 7800001181 UPC Can Code: 0780790
Beverages·9,152 affected·Oct 14, 2021
High RiskFDA
Keurig Dr Pepper
Polar Black Cherry Premium Seltzer 12 pack of 12oz cans UPC Cardboard Wrap Code: 7153700228, UPC Can Code: 7153700110
Food·7,849 affected·Oct 14, 2021
High RiskFDA
Keurig Dr Pepper
Target Good & Gather Mixed Berry Sparkling Water 8 pack of 12 oz. cans UPC can: 0 85239 11516 9, UPC outer Carton (8 pack): 0 85239 11345 5
Beverages·9,393 affected·Oct 14, 2021
High RiskFDA
Golden State Medical Supply Inc.
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Sh...
Oral Drugs·101 affected·Oct 14, 2021
High RiskFDA
Golden State Medical Supply Inc.
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, L...
Oral Drugs·49 affected·Oct 14, 2021
High RiskFDA
Biocheck, Inc.
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determ...
Diagnostic Devices·314 affected·Oct 14, 2021
High RiskFDA
Hill-rom Inc.
These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0...
Medical Devices·1,050 affected·Oct 14, 2021
High RiskFDA
Sedecal Sa
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Diagnostic Devices·851 affected·Oct 14, 2021
CriticalFDA
Lumenis, Inc.
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel ...
Medical Devices·11,064 affected·Oct 14, 2021
High RiskFDA
Beeken Biomedical, Llc
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Medical Devices·15 affected·Oct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Medical Devices·38 affected·Oct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Medical Devices·0 affected·Oct 14, 2021
High RiskFDA
The Kroger Co
Country Oven Yellow/Caramel Cake Single Slices, double layer cakes ( 48oz )
Bakery & Grains·6 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Caramel Apple Double Layer Cake 32 oz
Bakery & Grains·6 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Cinnamon Roll 4oz, 2.5oz
Food·230 affected·Oct 13, 2021
RecallFDA
The Kroger Co
Country Oven Yellow/Vanilla Cake 37oz
Bakery & Grains·4 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven White/Vanilla Cake 37oz
Bakery & Grains·4 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven White Cake 7lb, 13.5oz, 29oz
Bakery & Grains·34 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Marble Cake 7lb
Bakery & Grains·3 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Angel Food Cake 13 oz
Bakery & Grains·12 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Bowtie Danish 3oz
Food·144 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Cheese Pocket 4oz - 84 to a case
Dairy·84 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Chocolate/Vanilla Cake 37oz
Bakery & Grains·4 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Chocolate/Fudge Cake Single Slices, Double Layer Cake (50oz)
Bakery & Grains·6 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Red Velvet Cake 13oz, 28oz, single slices, Double Layer Cake (51 oz), 8oz
Bakery & Grains·62 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Yellow Cake 18.5oz, 7oz, 13.5oz, 42oz
Bakery & Grains·70 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Party Balloon Cake 48oz
Bakery & Grains·4 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Boston Cream Cake Double Layer Cake 28oz
Dairy·6 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Chocolate Cake 13.5oz, 60oz, 40oz
Bakery & Grains·60 affected·Oct 13, 2021
High RiskFDA
The Kroger Co
Country Oven Yellow/Fudge Cake 48oz, single slices
Bakery & Grains·11 affected·Oct 13, 2021
Medium RiskFDA
Ultra Seal Corporation
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Pack...
Oral Drugs·991,310 affected·Oct 13, 2021
Medium RiskFDA
Ultra Seal Corporation
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged...
Oral Drugs·519,600 affected·Oct 13, 2021
High RiskFDA
Ultra Seal Corporation
Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 896...
Oral Drugs·1,367,525 affected·Oct 13, 2021
High RiskFDA
Ultra Seal Corporation
ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Pa...
Oral Drugs·1,968,150 affected·Oct 13, 2021
High RiskFDA
Ultra Seal Corporation
AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Ca...
Oral Drugs·1,480,981 affected·Oct 13, 2021
Medium RiskFDA
Ultra Seal Corporation
North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Pack...
Oral Drugs·250,000 affected·Oct 13, 2021
High RiskFDA
Ultra Seal Corporation
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,...
Oral Drugs·42,394,018 affected·Oct 13, 2021
High RiskFDA
Ultra Seal Corporation
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 1116...
Oral Drugs·2,484,274 affected·Oct 13, 2021
High RiskFDA
Instrumentation Laboratory
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Diagnostic Devices·5,828 affected·Oct 13, 2021
High RiskFDA
Elekta, Inc.
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Medical Devices·1,072 affected·Oct 13, 2021
High RiskFDA
Cook Inc.
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visua...
Medical Devices·112 affected·Oct 13, 2021
RecallFDA
The Mustard Man Inc
The Mustard Man Inc Simply Peppered Mustard 8oz plastic bottles, 6 bottles per case
Food·1,739 affected·Oct 12, 2021
High RiskFDA
Vita Pharmacy, Llc Dba Talon Compounding Pharmacy
B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Te...
Injectable Drugs·1 affected·Oct 12, 2021
High RiskFDA
Vita Pharmacy, Llc Dba Talon Compounding Pharmacy
ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 7...
Injectable Drugs·4 affected·Oct 12, 2021