Browse Drug Recalls

1,749 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,749 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 1,749 FDA drug recalls, Class I.

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DateProductReasonClassFirm
Oct 2, 2023 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Us... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJEC... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of U... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Sep 29, 2023 ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA Microbial contamination of Non-Sterile Products Class I Biomic Sciences, LLC dba ION Intelligence of Na...
Sep 25, 2023 BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufact... Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate d... Class I Scynexis, Inc.
Sep 20, 2023 Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech In... Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP... Class I KVK-Tech, Inc.
Sep 8, 2023 TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride i... Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis Class I Church & Dwight Inc
Sep 8, 2023 SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. Class I Novartis Pharmaceuticals Corp.
Aug 26, 2023 Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... Non-Sterility Class I Dr. Berne's Whole Health Products
Aug 25, 2023 WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Br... Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenaf... Class I Hua Da Trading, Inc. dba Wefun Inc.
Aug 25, 2023 Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/D... Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,... Class I Marlex Pharmaceuticals, Inc.
Aug 3, 2023 Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (In... Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenaf... Class I APG SEVEN, INC
Jun 27, 2023 Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net con... Defective container: empty inhaler and leakage observed through the inhaler valve due to partiall... Class I Cipla USA, Inc.
Jun 23, 2023 Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 m... Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specific... Class I Lupin Pharmaceuticals Inc.
May 31, 2023 ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on... Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg we... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Apr 26, 2023 DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC... Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... Class I Gadget Island, Inc
Apr 26, 2023 Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by B... Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... Class I Gadget Island, Inc
Apr 26, 2023 NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power C... Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... Class I Gadget Island, Inc
Apr 20, 2023 G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric... Product mix-up: incorrect product was found inside the G-Supress DX product carton. Class I Novis PR, LLC dba Kramer Novis
Mar 27, 2023 Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solutio... Chemical Contamination: FDA testing found Presence of methanol Class I Jarman's Midwest Cleaning Systems, Inc.
Mar 27, 2023 SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STER... Chemical Contamination: FDA testing found Presence of methanol Class I Jarman's Midwest Cleaning Systems, Inc.
Mar 13, 2023 Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manuf... Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus ce... Class I Camber Pharmaceuticals Inc.
Feb 24, 2023 Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83... Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. Class I Global Pharma Healthcare Private Limited
Feb 14, 2023 Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31... Non-Sterility Class I Pharmedica USA, LLC
Feb 14, 2023 Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-S... Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and ace... Class I Nanomaterials Discovery Corporation
Feb 13, 2023 PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-c... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class I Volt Candy Wholesale Club
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Dec 23, 2022 Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Bur... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hyd... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Ca... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 22, 2022 Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Sing... Presence of Particulate Matter: Glass particulate matter detected in injectable. Class I Pfizer Inc.
Dec 19, 2022 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles... Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... Class I Spectrum Laboratory Products, Inc.
Dec 19, 2022 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a va... Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... Class I Spectrum Laboratory Products, Inc.
Dec 6, 2022 Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 05... Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... Class I Glaxosmithkline Consumer Healthcare Holdings DB...
Dec 6, 2022 Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever ... Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... Class I Glaxosmithkline Consumer Healthcare Holdings DB...
Dec 6, 2022 Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Relieve... Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... Class I Glaxosmithkline Consumer Healthcare Holdings DB...
Dec 1, 2022 Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syr... Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained pro... Class I BayCare Integrated Service Center, LLC /dba Bay...
Nov 29, 2022 Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufacture... Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomyc... Class I Accord Healthcare, Inc.
Nov 28, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Nov 28, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Nov 5, 2022 Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, pack... Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER ... Class I Adam's Polishes LLC
Oct 7, 2022 Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Sy... Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. Class I Viatris Inc

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.