Browse Drug Recalls
1,678 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,678 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 1,678 FDA drug recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in... | Subpotent Drug | Class III | Edenbridge Pharmaceuticals, 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 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, 1.25 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 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 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 |
| 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 20, 2023 | MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile O... | Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0%... | Class III | Imprimis NJOF, LLC |
| Sep 12, 2023 | Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, S... | Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. | Class III | Tolmar, Inc. |
| Sep 7, 2023 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... | Subpotent: Out of Specification result observed for low assay | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Sep 5, 2023 | Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalypto... | Incorrect/Undeclared Excipients. | Class III | Vi-Jon, LLC |
| Sep 1, 2023 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per cart... | Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged prod... | Class III | Amerisource Health Services LLC |
| Aug 29, 2023 | Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 9... | Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packag... | Class III | RB Health (US) LLC |
| Aug 23, 2023 | Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufa... | Defective Container: slow leakage under the cap | Class III | Contract Pharmaceuticals Limited Canada |
| Aug 17, 2023 | Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactu... | Cross contamination with other products | Class III | Lundbeck LLC |
| 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 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 | 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 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 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 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 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. |
| 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 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 5, 2023 | Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one ... | Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 27, 2023 | Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufact... | Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term st... | Class III | Lupin Pharmaceuticals Inc. |
| Jun 23, 2023 | PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only... | Failed Stability Specifications | Class III | Vivus, Inc. |
| Jun 13, 2023 | Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Ma... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | AVKARE LLC |
| Jun 12, 2023 | Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | Amring Pharmaceuticals Inc |
| Jun 6, 2023 | GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisit... | Labeling: Label Mix-up | Class III | HF Acquisition Co LLC |
| May 22, 2023 | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Com... | Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride | Class III | New England Life Care, Inc. dba Advanced Compou... |
| May 18, 2023 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by... | Failed Impurities/Degradation Specifications | Class III | Aurolife Pharma, LLC |
| May 8, 2023 | Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramusc... | Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the p... | Class III | Amneal Pharmaceuticals of New York, LLC |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 24, 2023 | Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablet... | Product mixup: one foreign tablet found in product. | Class III | The Harvard Drug Group |
| Apr 20, 2023 | Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per ... | Labeling: Typographical error on the upper left-hand side of the box and individual patch label t... | Class III | Bryant Ranch Prepack, Inc. |
| Apr 13, 2023 | Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / ... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition 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.