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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.