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
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·400 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·440 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·492 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·2,268 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·1,397 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·0 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·179 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·451 affected·Jun 14, 2018
High RiskFDA
Sca Pharmaceuticals, Llc
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Drugs·196 affected·Jun 14, 2018
RecallFDA
Nidek Inc.
RT-5100 Refractor, a component of the Epic-5100 System.
Medical Devices·85 affected·Jun 14, 2018
High RiskFDA
Abbott Laboratories, Inc.
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics Syst...
Medical Devices·2,521 affected·Jun 14, 2018
High RiskFDA
Maquet Sas
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; A...
Surgical Devices·151 affected·Jun 14, 2018
High RiskFDA
Lupin Somerset
Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), ...
Drugs·2,229,052 affected·Jun 13, 2018
High RiskFDA
Beekley Corporation
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
Medical Devices·3,384,024 affected·Jun 13, 2018
High RiskFDA
Beekley Corporation
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
Medical Devices·3,384,024 affected·Jun 13, 2018
High RiskFDA
Bard Medical Division
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indica...
Medical Devices·5,608 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 7402...
Medical Devices·64,642 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 7402...
Medical Devices·42,050 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 7402121...
Medical Devices·10,792 affected·Jun 13, 2018
RecallFDA
World Variety Produce Inc.
Melissa's Spicy Edamame: Lightly seasoned with Japanese Chile and Sesame Oil. 7 oz. (1.98g) Keep Refrigerated UPC: 0-45255-14637 6 c...
Dairy·1,662 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parklan...
Drugs·20 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Adv...
Drugs·120 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella ...
Drugs·225 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables H...
Oral Drugs·220 affected·Jun 12, 2018
Medium RiskFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Onl...
Oral Drugs·130,081 affected·Jun 12, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, N...
Oral Drugs·44,894 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of H...
Drugs·480 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houst...
Drugs·2,500 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Ho...
Drugs·500 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265...
Drugs·200 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 m...
Drugs·4,280 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. H...
Drugs·850 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Ave...
Drugs·240 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston,...
Drugs·740 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. ...
Drugs·900 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Ho...
Drugs·10,500 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt ...
Drugs·25 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 K...
Drugs·1,860 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center...
Drugs·120 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella...
Drugs·1,290 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Deser...
Drugs·175 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose s...
Drugs·100 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Commu...
Drugs·40 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265...
Drugs·130 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Ad...
Drugs·420 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willow...
Drugs·0 affected·Jun 12, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, N...
Oral Drugs·55,126 affected·Jun 12, 2018
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9...
Drugs·1,500 affected·Jun 12, 2018