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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

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DateProductReasonClassFirm
Jul 29, 2021 Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 9, 2021 Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramus... Lack of Assurance of Sterility Class II Innoveix Pharmaceuticals Inc
Jul 9, 2021 Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injec... Lack of Assurance of Sterility Class II Innoveix Pharmaceuticals Inc
May 11, 2021 C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Comp... Non-Sterility Class I People's Custom Rx and Clinical Care, LLC
Apr 26, 2021 Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multipl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Onl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx On... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 12, 2021 Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, ... Defective container; syringe content migrating past the seal of the plunger may cause a lack of a... Class II Edge Pharma, LLC
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... Class II CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... Class I CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... Class II CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... Class I CareFusion 213, LLC
Mar 11, 2021 Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial pac... Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may res... Class II Sagent Pharmaceuticals Inc
Feb 17, 2021 Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solut... Lack of Assurance of Sterility Class II The General Hospital Corporation
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-D... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), pa... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL),... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), ... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL,... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC ... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-do... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Te... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Dec 21, 2020 Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose... Lack of assurance of sterility: The results of sterility tests of seven batches of product were o... Class II Merck Sharp & Dohme
Dec 17, 2020 fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx On... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Sing... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA P... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dos... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syr... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA P... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Onl... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 5... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CI... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only,... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single D... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1m... Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. Class II Imprimis NJOF, LLC
Dec 17, 2020 PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only,... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals

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.