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Browse Drug Recalls

17,582 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,582 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 17,582 FDA drug recalls.

DateProductReasonClassFirm
Oct 3, 2023 Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular... Subpotent: Failing Test Results for Epinephrine Class III Imprimis NJOF, LLC
Oct 2, 2023 Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Co... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Sta... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, C... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Us... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL mult... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx o... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal adminis... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of U... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, C... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJEC... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compo... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL s... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 6... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalm... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, R... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Sep 29, 2023 ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA Microbial contamination of Non-Sterile Products Class I Biomic Sciences, LLC dba ION Intelligence of Na...
Sep 29, 2023 Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA Microbial contamination of Non-Sterile Products Class II Biomic Sciences, LLC dba ION Intelligence of Na...
Sep 29, 2023 ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* ... Microbial contamination of Non-Sterile Products Class II Biomic Sciences, LLC dba ION Intelligence of Na...
Sep 28, 2023 Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL... Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial.... Class II Eugia US LLC
Sep 28, 2023 Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pr... Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product r... Class II Padagis US LLC
Sep 25, 2023 BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufact... Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate d... Class I Scynexis, Inc.
Sep 22, 2023 Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx onl... Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two ... Class III West-Ward Columbus Inc
Sep 21, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 793... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe,... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL s... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx o... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syring... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAP... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixtu... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syrin... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admix... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total V... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syrin... Lack of assurance of sterility: 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.