Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 15, 2022 | Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufa... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 15, 2022 | Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) ... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 15, 2022 | Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 5... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 15, 2022 | Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15;... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 15, 2022 | Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manu... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 14, 2022 | PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a)... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | Vitae Enim Vitae Scientific, Inc. |
| Mar 14, 2022 | Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4... | Defective container | Class II | Athenex Pharma Solutions, LLC |
| Mar 14, 2022 | TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Sin... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | Vitae Enim Vitae Scientific, Inc. |
| Mar 14, 2022 | Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL ex... | Defective container | Class II | Athenex Pharma Solutions, LLC |
| Mar 14, 2022 | Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, ... | Defective container | Class II | Athenex Pharma Solutions, LLC |
| Mar 14, 2022 | Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, ... | Defective container | Class II | Athenex Pharma Solutions, LLC |
| Mar 14, 2022 | Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, ... | Defective container | Class II | Athenex Pharma Solutions, LLC |
| Mar 14, 2022 | Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag,... | Defective container | Class II | Athenex Pharma Solutions, LLC |
| Mar 14, 2022 | PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vial... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | Vitae Enim Vitae Scientific, Inc. |
| Mar 14, 2022 | PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials ... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | Vitae Enim Vitae Scientific, Inc. |
| Mar 14, 2022 | Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chl... | Defective container | Class II | Athenex Pharma Solutions, LLC |
| Mar 11, 2022 | Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit... | Labeling: Label Mix-Up | Class II | DASH Pharmaceuticals LLC |
| Mar 10, 2022 | ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solu... | CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specificatio... | Class II | Rock Town Distillery, Inc. |
| Mar 8, 2022 | Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per... | Sub Potent | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 17... | Super Potent and Failed Reconstitution Time | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution... | Product found to be Sub Potent or Exceeded reconstitution time | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Co... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compoun... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tail... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 m... | 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 | 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 | 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 | 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 | 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 |
| 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 | Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made C... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding | 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 | 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 | 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 | 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 |
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.