Browse Drug Recalls
6,322 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,322 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 6,322 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 7, 2022 | Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made ... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-via... | 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 |
| 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 | 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 | 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 | 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 | Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Re... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temp... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tai... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, T... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Ro... | 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 | 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 | Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tai... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Levocarnitine 500mg/mL, 30mL-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 | 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 | 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 | Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor M... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, R... | 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 | 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 | Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, ... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, 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 | Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg... | 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 | 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 | Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single ... | 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 | Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preserva... | 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 | 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 | Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic... | 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 | Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Prese... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Singl... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Dexamethasone sodium phosphate, sterile otic solution for injection Preservat... | 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 | Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syrin... | 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.