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Browse Drug Recalls

1,122 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,122 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 1,122 FDA drug recalls in 2023.

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DateProductReasonClassFirm
Aug 17, 2023 CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High 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) 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% / 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 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 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 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 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 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 EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Cen... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 16, 2023 Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Man... Failed dissolution specifications: below specification results at stability 12-month Class III Esperion
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 Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 ... Subpotent: Out of Specification for Assay Test at the 3-month time point. Class III Glenmark Pharmaceuticals Inc., USA
Aug 14, 2023 Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial,... Labeling: Missing Label; customer complaint received that labels were partially or completely pee... Class III Baxter Healthcare Corporation
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 14, 2023 Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL ... Failed Impurities/Degradation Specifications Class III Caplin Steriles Limited
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 Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottl... Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range. Class III Imprimis NJOF, 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 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 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 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 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 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 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 7, 2023 PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injec... Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot num... Class III Advanced Accelerator Applications USA, 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
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.
Aug 2, 2023 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B.... Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructi... Class III B. Braun Medical 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.
Jul 27, 2023 Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured fo... Failed Impurities/Degradation Specifications Class III ALEMBIC PHARMACEUTICALS, INC.
Jul 21, 2023 Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distri... cGMP deviations: Batch was released prior to approval. Class II Aurobindo Pharma USA Inc.
Jul 21, 2023 Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules pe... CGMP deviation: product released prior to supplier approval. Class II The Ritedose Corporation
Jul 21, 2023 Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distri... cGMP deviations: Batch was released prior to approval. Class II Aurobindo Pharma USA Inc.
Jul 20, 2023 FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL ... cGMP deviations: due to shipment of rejected units. Class II SCA Pharmaceuticals
Jul 18, 2023 Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, ... Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organ... Class III Ascend Laboratories, LLC
Jul 18, 2023 Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured b... Out of Specification result observed in content uniformity testing Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixt... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services 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.