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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
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 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 Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, ... Defective container Class II Athenex Pharma Solutions, LLC
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 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 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 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 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 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, ... Defective container Class II Athenex Pharma Solutions, LLC
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 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 Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured... FAILED CONTENT UNIFORMITY SPECIFICATIONS Class III Macleods Pharma Usa Inc
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 Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottle... Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydroc... Class I Jubilant Cadista Pharmaceuticals, Inc.
Mar 8, 2022 Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% S... Sub Potent Class III 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 T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) ... Super Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atro... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged... Sub Potent Class III 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 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 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 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 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 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 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 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 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 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 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 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 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 Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-via... 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 Vitamin D3 50,000IU/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 Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor M... 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 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 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 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 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 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 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 NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding 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

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.