Skip to main content

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
Abbott Diabetes Care, Inc.
FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C)....
Diabetes Devices·5 affected·Feb 19, 2014
High RiskFDA
Newman's Own Inc.
Newman's Own Salsa Con Queso, Medium All Natural Net Wt.16 oz., packaged in a glass jar UPC 0 20662 00353 9
Food·36,951 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia...
Cardiac Devices·220 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for ...
Cardiac Devices·6,583 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for ...
Cardiac Devices·39,128 affected·Feb 18, 2014
CriticalFDA
Hospira Inc.
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and ...
Medical Devices·26,765 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Cardiac Devices·3,541 affected·Feb 18, 2014
High RiskFDA
Remel Inc
Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke...
Medical Devices·40 affected·Feb 18, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix JG 9-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·5,200 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix DRNC, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·19,000 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
French Onion Dip Pre--mix CJ 7-3, in 50 lbs bags intended to be used in the manufacture of French onion dip
Produce·650 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Spinach Pre-mix HG 25-3, in 50 lbs bags intended to be used in the manufacture of dip
Produce·500 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix ACNC, in 45 lbs bags intended to be used in the manufacture of cheese dip
Dairy·495 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix JC 6-1, in 50 lbs bags intended to be used in the manufacture of dip
Dairy·28,500 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix EF 18-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·500 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix, LG 18-1,in 50 lbs bags, used in the manufacture of cheese dip
Dairy·7,650 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix ME 14-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·1,000 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix, CF 21-1, in 50 lbs bags, intended to be used in the manufacture of cheese dip
Dairy·10,300 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Monterey Jack Pre-mix EI 20-3, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·200 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Monterey Jack Pre-mix HI 10-3, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·6,000 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
All Natural Cheese Pre-mix IA 9-4, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·350 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
All Natural Cheese Pre-mix JF 12-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·2,900 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix JE 4-2, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·83,050 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Cheese Pre-mix JC 9-3, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·1,000 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Chipotle Cheese Pre-mix DA 15-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·1,000 affected·Feb 17, 2014
High RiskFDA
Custom Ingredients Llc
Natural Cheese Pre-mix DRWC DJ 6-2, in 50 lbs bags intended to be used in the manufacture of cheese dip
Dairy·4,350 affected·Feb 17, 2014
RecallFDA
Technidata S.a.
TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument a...
Medical Devices·85 affected·Feb 17, 2014
High RiskFDA
Walkmed Infusion, Llc
Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusi...
Medical Devices·797 affected·Feb 17, 2014
CriticalFDA
Falafel King Ent, Inc.
Falafel King Green Chile Hummus, 10 oz, Plastic Tub, packaged in 12count and 8 count cases. Labeled in part ** Falafel King green chile ...
Food·4,000 affected·Feb 14, 2014
High RiskFDA
Nature's Value Inc.
True Botanica brand Enzymes Plus, 45 CAPSULES, Product No. TB043-45, a Dietary Supplement --- Manufactured for True Botanica LLC, 1005 Ri...
Supplements·990 affected·Feb 14, 2014
CriticalFDA
Ice Cream Specialities
Chocolate Ice Cream manufactured under the Dairy Rich brand and packaged in a 1.75 quart (1.66 L) (56 oz.) carton.
Dairy·2,448 affected·Feb 14, 2014
CriticalFDA
Falafel King Ent, Inc.
Falafel King Green Chili Hummus Wrap, 8.5 oz individual packages of the Green Chili Hummus Wraps
Food·4,000 affected·Feb 14, 2014
CriticalFDA
Medisca Inc
CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution i...
Drugs·25 affected·Feb 14, 2014
CriticalFDA
Ben Venue Laboratories Inc
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
Drugs·5,131 affected·Feb 14, 2014
High RiskFDA
Agila Specialties Private Ltd.
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per...
Injectable Drugs·7,919 affected·Feb 14, 2014
High RiskFDA
Legacy Pharmaceutical Packaging
Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARM...
Oral Drugs·667,068 affected·Feb 14, 2014
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this corre...
Medical Devices·15 affected·Feb 14, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 ser...
Cardiac Devices·33 affected·Feb 14, 2014
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrum...
Surgical Devices·21 affected·Feb 14, 2014
High RiskFDA
Raysearch Laboratories Ab
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Medical Devices·251 affected·Feb 14, 2014
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ...
Medical Devices·36 affected·Feb 14, 2014
High RiskFDA
C. H. Guenther & Sons, Inc.
MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg)
Bakery & Grains·1,296 affected·Feb 13, 2014
High RiskFDA
Raymond-hadley Corp.
STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED BY STONEWALL KITCHE...
Bakery & Grains·7,476 affected·Feb 13, 2014
CriticalFDA
Diamond Foods Inc
Bakes Sea Salt Potato Chips, Kettle Brand, Item 07-10982-000. It is packaged in a 4 oz. retail bag, 15 bags per case. Bag UPC 84114 1...
Snacks & Candy·144 affected·Feb 13, 2014
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patc...
Topical Drugs·117,600 affected·Feb 13, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park...
Drugs·10 affected·Feb 13, 2014
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count pat...
Topical Drugs·187,860 affected·Feb 13, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enab...
Medical Devices·12 affected·Feb 13, 2014