Hazard Type

Product Quality Recalls

2,865 product recalls involving product quality. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

2,865Total Recalls
260Critical
322.2MUnits Affected
All Recalls

Every Product Quality Recall

Sorted by most recent. Click any recall for full details and safety information.

2,865 recalls
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United S...
Oral Drugs·15,576 affected·Jan 5, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United St...
Oral Drugs·16,560 affected·Jan 5, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, ...
Oral Drugs·4,608 affected·Jan 3, 2024
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, C...
Injectable Drugs·10,152 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd En...
Injectable Drugs·8,976 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO...
Injectable Drugs·7,548 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd En...
Injectable Drugs·13,920 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewoo...
Injectable Drugs·29,016 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewo...
Injectable Drugs·12,564 affected·Dec 28, 2023
RecallFDA
Amerisource Health Services Llc
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, C...
Oral Drugs·6,344 affected·Dec 26, 2023
CriticalFDA
Pfizer Inc.
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL ...
Injectable Drugs·34,000 affected·Dec 21, 2023
CriticalFDA
Pfizer
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, I...
Injectable Drugs·3,546 affected·Dec 21, 2023
CriticalFDA
Pfizer Inc.
8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe p...
Injectable Drugs·21,200 affected·Dec 21, 2023
CriticalFDA
Pfizer Inc.
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton...
Injectable Drugs·24,400 affected·Dec 21, 2023
High RiskFDA
Lupin Pharmaceuticals Inc.
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lup...
Oral Drugs·100 affected·Dec 20, 2023
RecallFDA
Glaxosmithkline Llc
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, ...
Inhaled / Nasal Drugs·67,508 affected·Dec 12, 2023
RecallFDA
Azurity Pharmaceuticals, Inc.
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 5...
Oral Drugs·2,220 affected·Dec 8, 2023
RecallFDA
Vita 360, Llc
Brand Name: SUPREX Plant Based Nutrition. Product Name: Carb & Sugar Block. Product Size: 120 Vegetable Cellulose Capsules per bottle. C...
Produce·1,999 affected·Dec 7, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512...
Oral Drugs·96,192 affected·Dec 4, 2023
High RiskFDA
Maquet Cardiovascular, Llc
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Medical Devices·554 affected·Dec 1, 2023
High RiskFDA
Anazaohealth Corporation
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las...
Injectable Drugs·3,363 affected·Nov 22, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
QMS Tacrolimus Calibrators, Product code 10015573
Medical Devices·10 affected·Nov 21, 2023
High RiskFDA
Kinder Farms Llc
KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distribu...
Oral Drugs·376,370 affected·Nov 13, 2023
High RiskFDA
Kinder Farms Llc
KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distribute...
Oral Drugs·591,684 affected·Nov 13, 2023
High RiskFDA
Golden State Medical Supply Inc.
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bott...
Oral Drugs·1,941 affected·Nov 10, 2023
High RiskFDA
Golden State Medical Supply Inc.
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bott...
Oral Drugs·5,626 affected·Nov 10, 2023
High RiskFDA
Golden State Medical Supply Inc.
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufact...
Oral Drugs·2,502 affected·Nov 10, 2023
RecallFDA
Taro Pharmaceuticals Inc.
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontari...
Drugs·11,196 affected·Nov 6, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)100...
Oral Drugs·25,776 affected·Nov 1, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c...
Oral Drugs·34,392 affected·Nov 1, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 M...
Oral Drugs·48,623 affected·Nov 1, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario...
Oral Drugs·4,074 affected·Nov 1, 2023
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC ...
Oral Drugs·8,448 affected·Oct 23, 2023
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2,...
Oral Drugs·16,944 affected·Oct 23, 2023
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceutical...
Oral Drugs·480 affected·Oct 20, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 0851...
Oral Drugs·7,392 affected·Oct 20, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 085...
Oral Drugs·2,304 affected·Oct 20, 2023
RecallFDA
Edenbridge Pharmaceuticals, Llc
Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbr...
Drugs·4,548 affected·Oct 20, 2023
CriticalFDA
Exela Pharma Sciences Llc
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-50...
Injectable Drugs·355,220 affected·Oct 18, 2023
CriticalFDA
Exela Pharma Sciences Llc
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenou...
Injectable Drugs·23,425 affected·Oct 18, 2023
High RiskFDA
Mc3 Inc
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxi...
Respiratory Devices·299 affected·Oct 11, 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
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
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
CriticalFDA
Pfizer Inc.
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx on...
Injectable Drugs·21,390 affected·Oct 2, 2023
High RiskFDA
Eugia Us Llc
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or I...
Injectable Drugs·1,626 affected·Sep 28, 2023
CriticalFDA
Resmed Ltd.
Astral 100 and Astral 150 ventilators
Respiratory Devices·55,279 affected·Sep 13, 2023