Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Sep 14, 2022 Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) ... Chemical Contamination: product found to contain benzene Class I Salon Technologies International Inc
Sep 13, 2022 Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for:... Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. Class II Lupin Pharmaceuticals Inc.
Sep 12, 2022 Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distrib... CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef... Class II Direct Rx
Sep 9, 2022 Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: ... Marketed Without An Approved NDA/ANDA; Unapproved new drug Class II Justified Laboratories
Sep 9, 2022 Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: ... Marketed Without An Approved NDA/ANDA; Unapproved new drug Class II Justified Laboratories
Sep 1, 2022 Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can... CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All I... Class II SUPERIOR GLOVE WORKS, LTD.
Aug 31, 2022 Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) t... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 31, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufact... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 30, 2022 Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon S... Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label. Class III Woodbine Products Co Inc
Aug 29, 2022 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually... Class II Teva Pharmaceuticals USA Inc
Aug 26, 2022 TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, R... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Caro... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Car... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infu... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, ... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion L... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, ... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infu... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC,... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 B... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Car... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusio... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 23, 2022 ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LE... Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules Class III Leading Pharma, LLC
Aug 23, 2022 Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distribute... CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ing... Class II Teva Pharmaceuticals USA Inc
Aug 22, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Aug 22, 2022 PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass... Presence of particulate matter Class I Pfizer Inc.
Aug 22, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Aug 17, 2022 Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By ... CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef... Class II Padagis US LLC
Aug 15, 2022 Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... Class II Ultra Chem Labs Corp
Aug 15, 2022 Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... Class II Ultra Chem Labs Corp
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Per... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT P... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL ... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mm... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... cGMP Deviations: deviations leading to potential cross-contamination. Class II Nephron Sc Inc
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net W... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Via... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Un... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 47... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevent... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 10, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT P... cGMP deviation: Product held outside of appropriate temperature storage conditions. Class II Family Dollar Stores, Llc.
Aug 8, 2022 Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride ... CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. Class II Midlab Incorporated

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.