Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 30, 2022 | QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, ... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECT... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial,... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6m... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, ... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials,... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, ... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 30, 2022 | QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg... | Lack of Assurance of Sterility | Class II | Northern VA Compounders PLLC |
| Dec 29, 2022 | Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium... | Lack of assurance of sterility: Bags have the potential to leak. | Class II | Pfizer Inc. |
| Dec 28, 2022 | Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL V... | Presence of Particulate Matter: Customer complaint of dark particles found inside the vial | Class II | Eugia US LLC |
| Dec 28, 2022 | Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 678... | Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on th... | Class II | Ascend Laboratories, LLC |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion ... | 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 | Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Hom... | 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 | 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 | 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 | 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 | 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 | BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton,... | Failed Impurities/Degradation Specifications | Class II | Amerisource Health Services LLC |
| 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 | 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 | ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services,... | 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 | Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cad... | Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| 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 | 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 | HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 ... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, u... | 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 | 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 | FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharma... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pu... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curli... | Lack of sterility assurance | Class II | Sentara Infusion Services |
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.