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
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High RiskFDA
Pharmedium Services, Llc
2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical ...
Drugs21 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical ...
Drugs1,280 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, S...
Drugs655 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compoun...
Drugs55 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Se...
Drugs1,470 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Casse...
Drugs220 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, ...
Drugs60 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical ...
Drugs5,727 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service C...
Drugs1,577 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag,...
Drugs445 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira...
Drugs2,194 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Servi...
Drugs435 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-48...
Drugs866 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag,...
Drugs750 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medic...
Drugs85 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag,...
Drugs115 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, S...
Drugs2,006 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Ba...
Drugs105 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, ...
Drugs380 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag,...
Drugs25 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag,...
Drugs1,277 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium ...
Drugs177 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, S...
Drugs1,527 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, ...
Drugs562 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service C...
Drugs180 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, S...
Drugs250 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical ...
Drugs1,234 affectedMay 5, 2016
RecallFDA
Kvk-tech, Inc.
Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03
Oral Drugs9,360 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, S...
Drugs480 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag,...
Drugs455 affectedMay 5, 2016
High RiskFDA
Pharmedium Services, Llc
0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-...
Drugs8,581 affectedMay 5, 2016
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support an...
Medical Devices770 affectedMay 5, 2016
High RiskFDA
Ellipse A/s
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Medical Devices14 affectedMay 5, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry s...
Diagnostic Devices24,940 affectedMay 5, 2016
High RiskFDA
Ellipse A/s
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Medical Devices25 affectedMay 5, 2016
High RiskFDA
Teleflex Medical
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A ...
Medical Devices6,390 affectedMay 5, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate A...
Diagnostic Devices13,147 affectedMay 5, 2016
CriticalFDA
Ohio Hickory Harvest Brand Products Inc.
Hickory Harvest FOODS Rucker's Cajun Mix 25 lb. bag in a box INGREDIENTS: Cajun Sesame Sticks***soybean oil***Sunflower Kernels, Hot & S...
Food685 affectedMay 4, 2016
CriticalFDA
Ohio Hickory Harvest Brand Products Inc.
Hickory Harvest FOODS Sweet & Salty Trail Mix 25 lb. UPC 0-36232-00510-0, 4.5oz UPC 0-36232-06075-5. INGREDIENTS: Peanuts, Raisins***Sun...
Food713 affectedMay 4, 2016
CriticalFDA
Bickel's Snack Foods Inc
Golden Gourmet Snacks Veggie Chips; Net Wt. 12 OZ; Bickel's Snack Foods, Inc., York, PA 17404 Lot codes: 26SEP16 Z4D1 and 26SEP16 Z5D1
Snacks & Candy201 affectedMay 4, 2016
CriticalFDA
Brown & Haley Inc.
Mountain Thins Trail Mix flavor, packaged in a stand-up film pouch (resealable), net wt. 5.3 oz. The UPC is 0 41770 33370 7
Food70,352 affectedMay 4, 2016
CriticalFDA
Ohio Hickory Harvest Brand Products Inc.
Big Y cranberry nut trail mix in plastic tub NET WT 20 OZ (1 LB 4 OZ) 567g INGREDIENTS: CRANBERRIES***PEANUTS, PEANUT OIL, RAISINS, SUNFL...
Produce155 affectedMay 4, 2016
CriticalFDA
Naturebox, Inc.
Dark Cocoa Nom Noms 4.5oz. (128g) UPC: 8 54557 00533 5 Lot 16083 Product is shipped directly to customers per individual order or t...
Dairy12,775 affectedMay 4, 2016
CriticalFDA
Ohio Hickory Harvest Brand Products Inc.
Roasted & Salted Sunflower Kernels under the following brand names: AMISH FARMS SALEM, OHIO 44460 5.5 oz plastic bag UPC 8 55993 20018 6,...
Snacks & Candy4,642 affectedMay 4, 2016
CriticalFDA
Sandridge Food Corporation
Crunchy Wheatberry Salad Kit 12.75 LB (5.78kg) ***SUNFLOWER SEED POUCH: INGREDIENTS SUNFLOWER KERNELS (Sunflower Kernels, Canola and/or P...
Produce1,559 affectedMay 4, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Sch...
Injectable Drugs355,150 affectedMay 4, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Sch...
Injectable Drugs40,280 affectedMay 4, 2016
High RiskFDA
Brainlab Ag
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Medical Devices27 affectedMay 4, 2016