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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
L. Perrigo Company
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95...
Oral Drugs·32,376 affected·Feb 9, 2023
High RiskFDA
L. Perrigo Company
Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 1...
Oral Drugs·6,216 affected·Feb 9, 2023
High RiskFDA
L. Perrigo Company
Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 722...
Oral Drugs·11,904 affected·Feb 9, 2023
High RiskFDA
L. Perrigo Company
Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Researc...
Oral Drugs·23,868 affected·Feb 9, 2023
High RiskFDA
L. Perrigo Company
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 490...
Oral Drugs·360,184 affected·Feb 9, 2023
High RiskFDA
L. Perrigo Company
aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo Company, All...
Oral Drugs·1,920 affected·Feb 9, 2023
High RiskFDA
Deroyal Industries Inc
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Medical Devices·27,200 affected·Feb 9, 2023
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 5...
Oral Drugs·4,320 affected·Feb 8, 2023
High RiskFDA
Apollo Care
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mo...
Drugs·215 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRA...
Medical Devices·10,037 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S4...
Medical Devices·19,057 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105...
Medical Devices·5,308 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DB...
Medical Devices·4,348 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5C...
Medical Devices·10,090 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF ...
Medical Devices·30,541 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S4...
Medical Devices·37,721 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS...
Medical Devices·23,850 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S431...
Medical Devices·186,889 affected·Feb 8, 2023
High RiskFDA
Texas Star Nut And Food Co., Inc.
Nature's Eats Cashew Crave Mix 8 oz. UPC 8-10087-30330-3, packaged in cello bags 12 packages per case
Food·19,800 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufacture...
Oral Drugs·113,571 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729...
Oral Drugs·72,376 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufact...
Oral Drugs·25,812 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle...
Oral Drugs·665,469 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 167...
Oral Drugs·147,736 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured b...
Oral Drugs·2,614 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: ...
Oral Drugs·139,332 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC ...
Oral Drugs·24,408 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 1...
Oral Drugs·256,106 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufacture...
Oral Drugs·1,970 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthc...
Injectable Drugs·3,164 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16...
Oral Drugs·176,323 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC ...
Oral Drugs·539,004 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 1...
Oral Drugs·469,944 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 1...
Oral Drugs·312,864 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets ND...
Oral Drugs·1,190,484 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by:...
Oral Drugs·1,440,652 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC ...
Oral Drugs·36,773 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactur...
Oral Drugs·120 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17...
Oral Drugs·31,116 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 167...
Oral Drugs·44,068 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles ...
Oral Drugs·43,302 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC...
Injectable Drugs·9,888 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: In...
Oral Drugs·25,344 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufac...
Oral Drugs·3,784 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Inta...
Oral Drugs·5,112 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Int...
Oral Drugs·14,928 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufa...
Oral Drugs·23,784 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas ...
Oral Drugs·2,641 affected·Feb 7, 2023