Browse Drug Recalls
1,122 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,122 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 1,122 FDA drug recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 14, 2023 | Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manu... | Failed pH Specifications | Class II | Baxter Healthcare Corporation |
| Nov 13, 2023 | KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Sus... | Failed Impurities/Degradation Specifications | Class II | KINDER FARMS LLC |
| Nov 13, 2023 | Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) e... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glyco... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), pa... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral ... | Failed Impurities/Degradation Specifications | Class II | KINDER FARMS LLC |
| Nov 13, 2023 | Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packag... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) pack... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% a... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Prop... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, T... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydro... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), pa... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%),... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL O... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 10, 2023 | PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-... | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... | Class II | Golden State Medical Supply Inc. |
| Nov 10, 2023 | Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose pack... | OOS for viscosity | Class III | Teva Pharmaceuticals USA, Inc |
| Nov 10, 2023 | Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25... | Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL ... | Class III | Fagron Compounding Services |
| Nov 10, 2023 | PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-73... | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... | Class II | Golden State Medical Supply Inc. |
| Nov 10, 2023 | PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-73... | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... | Class II | Golden State Medical Supply Inc. |
| Nov 9, 2023 | Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C;... | cGMP Deviations | Class II | Family Medical Supply Inc |
| Nov 9, 2023 | fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS U... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 ... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentratio... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag,... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentratio... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 m... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentr... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% To... | Product Mix-up: Incorrect Product Formulation | Class III | Right Value Drug Stores, LLC dba Carie Boyd's P... |
| Nov 9, 2023 | Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/m... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentrati... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey ... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.