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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
Mar 7, 2022 Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Com... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tail... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperat... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Tem... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperatur... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compo... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compo... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tai... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigera... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate,... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refriger... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refr... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made ... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) ... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, R... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Mad... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Feb 25, 2022 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun... Lack of sterility assurance: leaking bags Class II B. Braun Medical, Inc.
Feb 11, 2022 HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only... Non-sterility; bacterial contamination identified as Paenibacillus lautus. Class I Revive Rx LLC dba Revive Rx Pharmacy
Feb 4, 2022 PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton togethe... Non-sterility Class I CooperSurgical, Inc
Jan 11, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, ... Lack of Assurance of Sterility Class II Exela Pharma Sciences LLC
Dec 31, 2021 Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Dec 31, 2021 MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 1... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Dec 21, 2021 Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single... Lack of Assurance of Sterility Class II Ideal Specialty Apothecary, Inc. dba Ideal Phar...
Dec 6, 2021 Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / ... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Prese... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmi... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Sing... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free,... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syrin... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropp... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), ... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use S... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Prese... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dro... Lack of Assurance of Sterility. Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe... Lack of Assurance of Sterility Class II Edge Pharma, LLC

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.