Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 17, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with *... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total V... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, ... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, ... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Ce... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental ... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Ba... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, ... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume ... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Exce... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx O... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEP... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total V... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 m... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCI... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag,... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volum... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repac... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCI... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Cent... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, tota... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX ... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, P... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CAL... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag,... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 17, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIU... | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services, Inc. |
| Aug 15, 2023 | NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding. | Lack of Assurance of Sterility | Class II | TMC Acquisitions LLC dba Tailor Made Compounding |
| Aug 15, 2023 | Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding. | Lack of Assurance of Sterility | Class II | TMC Acquisitions LLC dba Tailor Made Compounding |
| Aug 14, 2023 | All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by In... | CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Al... | Class II | Inmar Supply Chain Solutions, LLC |
| Aug 11, 2023 | DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, p... | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Class II | Baxter Healthcare Corporation |
| Aug 11, 2023 | Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 pp... | Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsa... | Class II | AVKARE LLC |
| Aug 11, 2023 | Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FL... | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Class II | Baxter Healthcare Corporation |
| Aug 11, 2023 | Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NE... | Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% ... | Class II | AVKARE LLC |
| Aug 10, 2023 | hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v f... | Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons label... | Class II | Colgate Palmolive Company |
| Aug 9, 2023 | Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, pa... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged ... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and pota... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% ... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bot... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manuf... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 2, 2023 | Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-0... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 307... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc... | Failed dissolution specifications - results obtained were below spec average. | Class II | Aurobindo Pharma USA 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.