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
CriticalFDA
Real Kosher Ice Cream, Inc.
Soft Serve on the Go brand Caramel Vanilla flavor; 8 fl oz; UPC 0-91404-15131-3
Food·54,076 affected·Aug 8, 2023
High RiskFDA
Bickel's Snack Foods Inc
Butter Flavored Popcorn Naturally & Artificially Flavored, 8oz. UPC: 70175 06021 Packaged in clear plastic bags, 9 bags per case.
Dairy·6,048 affected·Aug 8, 2023
CriticalFDA
David Oppenheimer & Company I Llc
Zespri Organic Green Kiwi, product of New Zealand, one pallet of bulk loose organic green kiwifruit was shipped to one consignee in Chica...
Produce·1 affected·Aug 8, 2023
CriticalFDA
David Oppenheimer & Company I Llc
Zespri Organic Green Kiwi, product of New Zealand, perishable, packaged in plastic clamshell, net wt. 1lb. UPC 818849020093. Distributed ...
Food·4,568 affected·Aug 8, 2023
CriticalFDA
Real Kosher Ice Cream, Inc.
Soft Serve on the Go brand Vanilla Chocolate flavor; 8 fl oz; UPC 0-91404-15129-0 Soft Serve on the Go brand Parve Vanilla Chocolate fla...
Snacks & Candy·54,076 affected·Aug 8, 2023
CriticalFDA
Real Kosher Ice Cream, Inc.
Soft Zero on the Go brand Lite Peanut Butter flavor; 8 fl oz; UPC 0-91404-15285-3
Dairy·54,076 affected·Aug 8, 2023
High RiskFDA
Oculus Optikgeraete Gmbh
Oculus Pentacam AXL , Ref 70100, CE 0123
Medical Devices·364 affected·Aug 8, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Medical Devices·124,773 affected·Aug 8, 2023
High RiskFDA
Fx Shoulder
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Medical Devices·4 affected·Aug 8, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Diagnostic Devices·4,966 affected·Aug 8, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Medical Devices·124,773 affected·Aug 8, 2023
High RiskFDA
Oculus Optikgeraete Gmbh
Oculus Myopia Master , Ref 68100, CE 0123
Medical Devices·173 affected·Aug 8, 2023
High RiskFDA
Ge Medical Systems Information Technologies Inc
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Medical Devices·81 affected·Aug 8, 2023
RecallFDA
Advanced Accelerator Applications Usa, Inc.
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accel...
Injectable Drugs·10 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high v...
Medical Devices·5,155 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum ...
Medical Devices·109 affected·Aug 7, 2023
High RiskFDA
B. Braun Medical, Inc.
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid...
Medical Devices·604,800 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a c...
Medical Devices·224 affected·Aug 7, 2023
High RiskFDA
B. Braun Medical, Inc.
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/f...
Medical Devices·534,000 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix b...
Medical Devices·231 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone ce...
Medical Devices·16 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a...
Medical Devices·8 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement wi...
Medical Devices·652 affected·Aug 7, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT Chemistry Products ALKP Slides
Medical Devices·402,966 affected·Aug 5, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT Chemistry Products TBIL-ALKP Slides
Medical Devices·52,456 affected·Aug 5, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Surgical Devices·20 affected·Aug 4, 2023
CriticalFDA
Medline Industries, Lp - Northfield
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Medical Devices·18,000 affected·Aug 4, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Surgical Devices·10 affected·Aug 4, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
Medical Implants·0 affected·Aug 4, 2023
High RiskFDA
Encore Medical, Lp
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 3...
Surgical Devices·64 affected·Aug 4, 2023
High RiskFDA
Ingomar Packing Co
3/4" Diced Tomatoes in Juice packed in 55 gallon metal drums
Beverages·178 affected·Aug 3, 2023
High RiskFDA
Ingomar Packing Co
1/2" Diced Tomatoes in Juice packed in 55 gallon fiber drums
Beverages·4,038 affected·Aug 3, 2023
CriticalFDA
Apg Seven, Inc
Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stan...
Oral Drugs·120 affected·Aug 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
Medical Devices·324,451 affected·Aug 3, 2023
High RiskFDA
Ansell Healthcare Products Llc
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Surgical Devices·378 affected·Aug 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Surgical Devices·18 affected·Aug 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instr...
Surgical Devices·58 affected·Aug 3, 2023
High RiskFDA
Naturebest Pre-cut & Produce Llc
SALAD KIT-NO COLOR-11CT LETTUCE-4 WAY/MIX-4/5# LETTUCE-ROM/GRN LF 60/40-4/3# LETTUCE-ROMAINE-SHREDDED-4/5# LETTUCE-ROM-1x1-GRN ONLY-6/2# ...
Produce·90 affected·Aug 2, 2023
High RiskFDA
Get Fresh Produce, Inc.
Garden Cut Lettuce Greek Mix Salad (product number 10149) 10 LB packed in corrugated boxes with an inner plastic bag. Product consists o...
Produce·3,410 affected·Aug 2, 2023
High RiskFDA
Pearson Foods Corporation
Pearson Foods Lettuce Romaine. 1, 2.5lb bag per case
Produce·690 affected·Aug 2, 2023
High RiskFDA
Crispy Bagel Co., Inc.
Blueberry Artificially Flavored Bagels By Lidl NET WT 20 OZ (1 LB 4 OZ) 567 g UPC: 2099 0305 Packaged in a plastic bag
Produce·3,020 affected·Aug 2, 2023
High RiskFDA
Rmjv, Lp Dba Fresh Creative Foods
Fresh Creative Foods Caesar Salad Kit; 3.30 lbs per bag; film bags, individually sealed inside cardboard case; total package size: 6.6 lb...
Produce·1,210 affected·Aug 2, 2023
High RiskFDA
Get Fresh Produce, Inc.
Garden Cut Romaine 1x1 Chopped 6/2 LB (product number 9386) packed in corrugated boxes with an inner plastic bag (6, 2lb bags per case)
Food·1,404 affected·Aug 2, 2023
High RiskFDA
Parker Laboratories, Inc.
Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl...
Topical Drugs·250 affected·Aug 2, 2023
High RiskFDA
Parker Laboratories, Inc.
Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03)...
Topical Drugs·8 affected·Aug 2, 2023
High RiskFDA
Parker Laboratories, Inc.
Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. ...
Topical Drugs·40 affected·Aug 2, 2023
RecallFDA
B. Braun Medical Inc.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Injectable Drugs·43,812 affected·Aug 2, 2023
High RiskFDA
Aurobindo Pharma Usa Inc.
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Oral Drugs·9,890 affected·Aug 2, 2023