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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTAB... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
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 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 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 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 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 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 Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/... 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 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 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 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 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 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 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 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 ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services,... 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion... 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.