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 |
|---|---|---|---|---|
| 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 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 | 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 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 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 | 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 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 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 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 | 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 | 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 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 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 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 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 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 | 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 | 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 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, 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 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 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 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 (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 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 |
| Oct 4, 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 |
| Oct 4, 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 |
| Sep 29, 2022 | Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: AL... | Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets | Class I | Golden State Medical Supply Inc. |
| 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 |
| 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. |
| Jul 29, 2022 | Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.... | Chemical contamination: presence of benzene | Class I | Edgewell Personal Care Brands, LLC |
| Jul 22, 2022 | SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack wi... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil. | Class I | Distributor RFR, LLC. |
| Jul 21, 2022 | SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per ... | Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil. | Class I | Ultra Supplement LLC |
| Jul 15, 2022 | Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl ... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), G... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), D... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz)... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon F... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flav... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
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.