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Browse Drug Recalls

25 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 25 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 25 FDA drug recalls.

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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

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.