Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 6, 2024 | Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... | Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec... | Class II | B. Braun Medical Inc |
| Mar 5, 2024 | Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactu... | Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. | Class II | Thea Pharma, Inc. |
| Feb 29, 2024 | hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bot... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manuf... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 m... | Lack of Assurance of Sterility: Firm did not perform process validation. | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Feb 29, 2024 | TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufacture... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Ma... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manu... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenou... | Lack of Assurance of Sterility: Firm did not perform process validation. | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Jan 30, 2024 | Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Package... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrol... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Pa... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 10, 2024 | Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for I... | Lack of Sterility Assurance: Aseptic process simulation failure. | Class II | BE PHARMACEUTICALS AG |
| Dec 28, 2023 | DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, pack... | Lack of Sterility Assurance | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 22, 2023 | ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL... | Lack of assurance of sterility. | Class II | Wells Pharma of Houston 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 | 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 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 |
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.