Browse Drug Recalls

1,732 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,732 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 1,732 FDA drug recalls, Class I.

Clear
DateProductReasonClassFirm
Mar 5, 2019 LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containi... Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approve... Class I USA LESS Inc.
Feb 22, 2019 Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per pac... Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutrami... Class I Golean Detox US
Feb 13, 2019 White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 ... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. Class I Todd Holiday dba Sunstone Organics
Feb 13, 2019 Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gr... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. Class I Todd Holiday dba Sunstone Organics
Feb 13, 2019 Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. Class I Todd Holiday dba Sunstone Organics
Feb 13, 2019 White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) ... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. Class I Todd Holiday dba Sunstone Organics
Feb 1, 2019 Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx... Presence of Particulate Matter: particulate matter identified as copper salts Class I Mylan Institutional Inc
Jan 25, 2019 the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pru... Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... Class I Natures Rx
Jan 8, 2019 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Hap... Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... Class I Happy Together, Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL L... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL ... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 6818... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (ND... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 6... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (ND... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 14, 2018 Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%),... Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain unde... Class I Results RNA, LLC
Dec 11, 2018 Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Dec 11, 2018 Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Nov 29, 2018 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable So... Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per ... Class I Advanced Pharma Inc.
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Nov 5, 2018 puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115,... Non-Sterility: Product manufactured under non-sterile production conditions. Class I Kadesh International
Oct 26, 2018 Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), F... Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and ... Class I Dr. Reddy's Laboratories, Inc.
Oct 3, 2018 Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed ... Microbial Contamination of Non-Sterile Products Class I Silver Star Brands
Oct 3, 2018 Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed... Microbial Contamination of Non-Sterile Products Class I Silver Star Brands
Oct 3, 2018 Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distribu... Microbial Contamination of Non-Sterile Product Class I Silver Star Brands
Oct 3, 2018 Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed ... Microbial Contamination of Non-Sterile Products Class I Silver Star Brands
Sep 17, 2018 robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, ... Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly... Class I Endo Pharmaceuticals, Inc.
Aug 27, 2018 Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Sing... Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the... Class I SCA Pharmaceuticals, Inc.
Aug 27, 2018 Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative ... Subpotent Drug: Product may not have the active ingredient present in the bag. Class I QuVa Pharma, Inc.
Aug 23, 2018 Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ... Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ... Class I Hellolife
Aug 23, 2018 Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ... Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ... Class I Hellolife
Aug 23, 2018 Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ... Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ... Class I Hellolife
Aug 23, 2018 Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: ... Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, includ... Class I Hellolife
Aug 21, 2018 Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufact... Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets US... Class I Accord Healthcare, Inc.
Aug 15, 2018 Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero... Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 ... Class I Hetero Labs Limited Unit V
Aug 13, 2018 Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Livin... Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of... Class I Living Well Remedies, LLC
Aug 3, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-c... Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... Class I Westminster Pharmaceuticals LLC
Aug 3, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg),... Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... Class I Westminster Pharmaceuticals LLC
Aug 3, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-... Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... Class I Westminster Pharmaceuticals LLC
Aug 3, 2018 Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL)... Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas a... Class I Product Quest Manufacturing LLC
Aug 3, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100... Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... Class I Westminster Pharmaceuticals LLC
Aug 3, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100... Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... Class I Westminster Pharmaceuticals LLC
Jul 20, 2018 NET Remedies #7 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: Ki... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Aller-Detox: Water Chemicals U.S., 2 fl. oz. (59 mL), ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx CS-Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Female Discomforts, 2 fl. oz. (59 mL)... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine for kids! Newborn Tonic Homeopathic, 2 fl. oz. (5... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Arthritis Pain & Joint Relief Soulagement De La Douleur Arthritiqu... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Breast Cyst & Discomforts, 2 fl. oz. (59 mL), King Bio... Microbial contamination Class I King Bio 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.