Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 30, 2023 | V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioAc... | Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X i... | Class III | Grato Holdings, Inc. |
| Oct 27, 2023 | Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-... | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet wit... | Class III | NCS Healthcare of Kentucky Inc |
| Oct 27, 2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distribute... | Failed Dissolution Specifications | Class II | Amneal Pharmaceuticals of New York, LLC |
| Oct 27, 2023 | Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card ... | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet wit... | Class III | NCS Healthcare of Kentucky Inc |
| Oct 26, 2023 | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, M... | Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution wi... | Class III | VistaPharm LLC |
| Oct 23, 2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30... | Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Oct 23, 2023 | Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL uni... | Failed Content Uniformity Specifications | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 23, 2023 | Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Ma... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 20, 2023 | Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only,... | Sub-potent Drug: Lower potency than labeled. | Class III | Zyla Life Sciences US Inc. |
| Oct 20, 2023 | Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukam... | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Class I | Botanical Be |
| Oct 20, 2023 | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4... | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... | Class II | Omega & Delta Co., Inc. |
| Oct 20, 2023 | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in... | Subpotent Drug | Class III | Edenbridge Pharmaceuticals, LLC |
| Oct 20, 2023 | Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenz... | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Class I | Botanical Be |
| Oct 20, 2023 | Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottle... | Failed Viscosity Specifications: Out-of-specification test results for viscosity | Class II | ITF PHARMA INC |
| Oct 20, 2023 | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237... | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... | Class II | Omega & Delta Co., Inc. |
| 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 | Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distribu... | Failed Impurities/Degradation Specifications. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 20, 2023 | Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 ... | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... | Class II | Omega & Delta Co., Inc. |
| Oct 20, 2023 | Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distrib... | Failed Impurities/Degradation Specifications. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 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, 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 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, 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 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 | 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 | ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 ... | 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 | 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-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 | 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 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 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 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 | Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets... | Failed Dissolution Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES 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 | 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 | 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 | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL mult... | 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 | 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 | 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 | 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 |
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.