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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 20, 2023 | Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottl... | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Class I | Botanical Be |
| Oct 20, 2023 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-cou... | Failed Impurities/Degradation Specifications | Class III | Glenmark Pharmaceuticals Inc., USA |
| Oct 20, 2023 | Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Man... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dro... | CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. | Class II | Safecor Health, LLC |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx ... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 18, 2023 | Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottle... | Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. | Class I | VistaPharm LLC |
| Oct 18, 2023 | Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Si... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 18, 2023 | Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender ... | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... | Class II | Integrity Bio-Chemicals LLC |
| Oct 18, 2023 | Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Sc... | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... | Class II | Integrity Bio-Chemicals LLC |
| Oct 18, 2023 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL S... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 18, 2023 | Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla ... | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... | Class II | Integrity Bio-Chemicals LLC |
| Oct 18, 2023 | ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 ... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 17, 2023 | Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz... | Failed Excipient Specifications: high content of ethylene glycol (EG) | Class III | VistaPharm LLC |
| Oct 17, 2023 | Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bott... | Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect bar... | Class III | AbbVie Inc. |
| Oct 16, 2023 | THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blis... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenaf... | Class I | Noah's Wholesale LLC |
| Oct 13, 2023 | Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distribute... | Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast S... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2023 | Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail sto... | CGMP Deviations: OTC products were stored outside of labeled temperature requirements. | Class II | Dollar Tree Distribution, Inc. |
| Oct 4, 2023 | Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ing... | CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and release... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 4, 2023 | Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06... | Labeling: Not Elsewhere Classified | Class III | Denver Solutions, LLC DBA Leiters Health |
| Oct 4, 2023 | Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets... | Failed Dissolution Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 4, 2023 | VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only... | Labeling: Not Elsewhere Classified | Class III | Denver Solutions, LLC DBA Leiters Health |
| Oct 4, 2023 | VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx onl... | Labeling: Not Elsewhere Classified | Class III | Denver Solutions, LLC DBA Leiters Health |
| 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 | 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 HCl 2.5%) ophthalmic solution, 15 mL... | 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 | 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 | 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 | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL mult... | 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 | 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 | 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 | 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 | 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 | TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalm... | 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 | 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 | 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 chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, R... | 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 | 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-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by ... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| 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 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 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 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. |
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.