Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 27, 2022 | FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharma... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion ... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infus... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx On... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Ph... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | 0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LI... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infu... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only,... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infus... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharma... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services,... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sent... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pha... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | MORPHINE Sulfate (a) 1MG/ML IN NS 350ML, (b) 5MG/ML IN NS 200ML, pain, Rx Onl... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Hom... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiv... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used w... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home p... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, R... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx On... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home I... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pha... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c)... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML,... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG ... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7M... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used w... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home I... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sen... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, anti... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500M... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG ... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Se... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27G... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 2... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infu... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 22, 2022 | GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 293... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innova... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED ... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 ... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
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.