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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68,659 recalls
High RiskFDA
Advance-esthetic Llc
MED-810A Zemits NDPrime Laser products
Medical Devices·19 affected·Oct 9, 2023
High RiskFDA
Hinterland Dairy Inc
Hinterland Dairy Farmstead Cheese Happy Jack Monterey Jack Cheese, packaged in bulk and 8oz packages.
Dairy·20 affected·Oct 6, 2023
High RiskFDA
Hinterland Dairy Inc
Hinterland Dairy Farmstead Cheese French Onion + Chive, a jack-style cheese, packaged in 8oz packages.
Dairy·24 affected·Oct 6, 2023
High RiskFDA
Intuitive Surgical, Inc.
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Medical Devices·317 affected·Oct 6, 2023
High RiskFDA
Peter Lazic Gmbh
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Medical Devices·10 affected·Oct 6, 2023
High RiskFDA
Leoni Cia Cable Systems
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiolo...
Medical Devices·1 affected·Oct 6, 2023
High RiskFDA
Peter Lazic Gmbh
D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
Medical Devices·63 affected·Oct 6, 2023
High RiskFDA
Dollar Tree Distribution, Inc.
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
Drugs·4,261,383 affected·Oct 5, 2023
High RiskFDA
Carefusion 303, Inc.
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1...
Medical Devices·2,679 affected·Oct 5, 2023
High RiskFDA
Encore Medical, Lp
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Medical Devices·17 affected·Oct 5, 2023
CriticalFDA
Th Searcy Llc
Guilt Free No Sugar Added Ice Cream Homemade Vanilla 1.5qts
Dairy·5,750 affected·Oct 4, 2023
RecallFDA
Denver Solutions, Llc Dba Leiters Health
VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood...
Injectable Drugs·33,480 affected·Oct 4, 2023
RecallFDA
Denver Solutions, Llc Dba Leiters Health
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood,...
Injectable Drugs·25,908 affected·Oct 4, 2023
RecallFDA
Sun Pharmaceutical Industries Inc
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industr...
Oral Drugs·144 affected·Oct 4, 2023
RecallFDA
Denver Solutions, Llc Dba Leiters Health
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Co...
Injectable Drugs·6,276 affected·Oct 4, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufacture...
Drugs·0 affected·Oct 4, 2023
High RiskFDA
Family Dollar Stores, Llc.
MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935
Medical Devices·329,044 affected·Oct 4, 2023
High RiskFDA
Visgeneer, Inc.
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bot...
Medical Devices·2,580 affected·Oct 4, 2023
High RiskFDA
Family Dollar Stores, Llc.
DENTEMP ONE STEP .077OZ, SKU 902139
Medical Devices·329,044 affected·Oct 4, 2023
High RiskFDA
Philips North America
Allura Xper IGTS Fixed Systems
Medical Devices·0 affected·Oct 4, 2023
High RiskFDA
Family Dollar Stores, Llc.
FIRST RESPONSE 2 CT, SKU 902343
Medical Devices·329,044 affected·Oct 4, 2023
High RiskFDA
Philips North America
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Medical Devices·0 affected·Oct 4, 2023
High RiskFDA
Family Dollar Stores, Llc.
ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
Medical Devices·329,044 affected·Oct 4, 2023
High RiskFDA
Philips North America
Veradius Unity Mobile Surgery C-arm
Medical Devices·0 affected·Oct 4, 2023
High RiskFDA
Family Dollar Stores, Llc.
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
Medical Devices·329,044 affected·Oct 4, 2023
High RiskFDA
St. Jude Medical
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery press...
Cardiac Devices·36,153 affected·Oct 4, 2023
High RiskFDA
Baxter Healthcare Corporation
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053,...
Medical Devices·499 affected·Oct 4, 2023
High RiskFDA
Becton Dickinson Infusion Therapy Systems Inc.
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Surgical Devices·528,000 affected·Oct 4, 2023
RecallFDA
Imprimis Njof, Llc
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resal...
Injectable Drugs·364 affected·Oct 3, 2023
High RiskFDA
Roche Diagnostics Operations, Inc.
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; I...
Diagnostic Devices·5,263 affected·Oct 3, 2023
High RiskFDA
Maisie Jane's California Sunshine Products Inc.
Maisie Jane's Smooth almond butter, 12 oz glass jar, 6 units per case, shelf stable
Dairy·4,834 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14...
Drugs·9,673 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Drugs·4,972 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Ri...
Drugs·2,176 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Par...
Injectable Drugs·130 affected·Oct 2, 2023
CriticalFDA
Pfizer Inc.
2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx o...
Injectable Drugs·3,200 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawan...
Ophthalmic Drugs·1,598 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by...
Injectable Drugs·2,484 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Phar...
Ophthalmic Drugs·1,693 affected·Oct 2, 2023
CriticalFDA
Pfizer Inc.
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per c...
Injectable Drugs·24,900 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Ton...
Ophthalmic Drugs·128 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmace...
Inhaled / Nasal Drugs·860 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkwa...
Drugs·881 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Rive...
Injectable Drugs·26 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 3...
Ophthalmic Drugs·662 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Ton...
Injectable Drugs·2,862 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tona...
Drugs·201 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmac...
Injectable Drugs·136 affected·Oct 2, 2023