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
B&g Foods North America, Inc
Food Club Garlic Powder, 5.37 ounce bottles, 12 bottles per case. " Best 324A0 C By NOV 19 22 / Best 325A0 By NOV 20 22
Food·1,301 affected·Dec 22, 2020
CriticalFDA
American Blue Ribbon Holdings Llc
9" French Silk Base, Item 7545, Count per case 6 Ea., Case Weight 12 lb. 3 oz. UPC 50796220075458. Keep Frozen.
Frozen Food·390 affected·Dec 22, 2020
CriticalFDA
Gh Foods Ca Llc
Spinach and Basil Pasta Salad Kit 2/5 lb. UPC: 20826766811438 Sold at Whole Foods Stores
Produce·3 affected·Dec 22, 2020
RecallFDA
Strides Pharma Inc.
NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India...
Oral Drugs·960 affected·Dec 22, 2020
RecallFDA
Edge Pharma, Llc
Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge...
Injectable Drugs·60 affected·Dec 22, 2020
High RiskFDA
Abbott Point Of Care Inc.
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 a...
Diabetes Devices·2,820,000 affected·Dec 22, 2020
High RiskFDA
Cytocell Ltd.
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71...
Medical Devices·72 affected·Dec 22, 2020
High RiskFDA
Sun Valley Foods Llc
Material Number: 7002 3/8 Diced Green Chile INGREDIENTS: Green Chilies, Citric Acid PRODUCT OF: MEXICO UNIT OF MEASURE: 440 +/- 5 LBS pa...
Food·240 affected·Dec 21, 2020
High RiskFDA
Merck Sharp & Dohme
Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subs...
Injectable Drugs·106,503 affected·Dec 21, 2020
CriticalFDA
Getinge Group Logistics America, Llc
Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying...
Surgical Devices·189 affected·Dec 21, 2020
High RiskFDA
Hardy Diagnostics
Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type:...
Cardiac Devices·820 affected·Dec 21, 2020
High RiskFDA
Omnilife Science Inc.
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replac...
Medical Devices·2 affected·Dec 21, 2020
High RiskFDA
Omnilife Science Inc.
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip repla...
Medical Devices·3 affected·Dec 21, 2020
High RiskFDA
Nihon Kohden America Inc
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 0493192110...
Diagnostic Devices·189 affected·Dec 21, 2020
CriticalFDA
Jr Simplot Company - Headquarters
SPUD-QUEEN LATTICE CUT - SKIN ON FROZEN POTATOES, master case SKU 10071179 041290. Distributed by Mid America Potato Company P.O. BOX 93...
Produce·400 affected·Dec 18, 2020
High RiskFDA
Water Gardens Confections Llc
Macey's Kong Popcorn, 24 oz., in plastic zip pouch. UPC: 0-41172-00046-7, Manufactured By: Water Gardens Confections, LLC, Orem, Utah, 8...
Snacks & Candy·7,736 affected·Dec 18, 2020
RecallFDA
Kvk-tech, Inc.
Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 ...
Oral Drugs·528 affected·Dec 18, 2020
High RiskFDA
Laerdal Medical (suzhou) Co., Ltd.
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended f...
Respiratory Devices·5,035 affected·Dec 18, 2020
High RiskFDA
Ansh Labs, Llc
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CO...
Medical Devices·327 affected·Dec 18, 2020
CriticalFDA
Hill-rom, Inc.
Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabi...
Medical Devices·10,470 affected·Dec 18, 2020
High RiskFDA
Smith & Nephew, Inc.
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium visc...
Medical Implants·5,190 affected·Dec 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for ...
Diagnostic Devices·41 affected·Dec 18, 2020
High RiskFDA
Topcon Medical Systems, Inc.
Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professi...
Medical Devices·13 affected·Dec 18, 2020
High RiskFDA
Sca Pharmaceuticals
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow ...
Injectable Drugs·428 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd.,...
Injectable Drugs·7,257 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow ...
Drugs·3,152 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little R...
Injectable Drugs·9,416 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 R...
Drugs·1,774 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Wind...
Drugs·5,990 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755...
Injectable Drugs·50 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd.,...
Injectable Drugs·1,879 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barc...
Drugs·952 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barc...
Drugs·1,614 affected·Dec 17, 2020
High RiskFDA
Imprimis Njof, Llc
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledg...
Injectable Drugs·6,520 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, ...
Injectable Drugs·6,710 affected·Dec 17, 2020
High RiskFDA
Cipla
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kur...
Oral Drugs·6,491 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT...
Injectable Drugs·1,930 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 700...
Drugs·1,880 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 060...
Drugs·390 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode...
Drugs·5,067 affected·Dec 17, 2020
High RiskFDA
Cipla
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kur...
Oral Drugs·289,350 affected·Dec 17, 2020
High RiskFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zu...
Injectable Drugs·490,633 affected·Dec 17, 2020
High RiskFDA
Ascend Laboratories Llc
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laborator...
Oral Drugs·9,524 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 700040...
Drugs·7,275 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow ...
Drugs·116 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rain...
Injectable Drugs·11,075 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcod...
Drugs·2,834 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) ...
Injectable Drugs·1,056 affected·Dec 17, 2020