Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 27, 2024 | NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottl... | Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month... | Class III | Esperion |
| Mar 25, 2024 | Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufa... | Failed Impurities/Degradation Specifications | Class III | Novitium Pharma LLC |
| Mar 4, 2024 | Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufact... | Cross Contamination with Other Products:(mycophenolate mofetil). | Class III | Novitium Pharma LLC |
| Feb 20, 2024 | Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured fo... | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... | Class III | Contract Pharmaceuticals Limited Canada |
| Feb 20, 2024 | Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured... | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... | Class III | Contract Pharmaceuticals Limited Canada |
| Feb 9, 2024 | Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076... | Failed Dissolution Specifications: results slightly under spec at at 9-months. | Class III | Stason Pharmaceuticals, Inc. |
| Feb 1, 2024 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit d... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged... | Class III | Amerisource Health Services LLC |
| Jan 25, 2024 | Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 25, 2024 | Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic reg... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Dec 26, 2023 | Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose c... | Superpotent drug: Assay results were slightly above specification at the time zero point. | Class III | Amerisource Health Services LLC |
| Dec 12, 2023 | ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg.... | Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification | Class III | GlaxoSmithKline LLC |
| Dec 8, 2023 | Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufa... | Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylid... | Class III | Azurity Pharmaceuticals, Inc. |
| Nov 22, 2023 | buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets... | Failed Dissolution Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 20, 2023 | Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured ... | Failed Dissolution Specifications | Class III | Siegfried Barbera, SL |
| Nov 10, 2023 | Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose pack... | OOS for viscosity | Class III | Teva Pharmaceuticals USA, Inc |
| Nov 10, 2023 | Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25... | Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL ... | Class III | Fagron Compounding Services |
| Nov 9, 2023 | LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% To... | Product Mix-up: Incorrect Product Formulation | Class III | Right Value Drug Stores, LLC dba Carie Boyd's P... |
| Nov 6, 2023 | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, ... | Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone relat... | Class III | Taro Pharmaceuticals Inc. |
| 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 | 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 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 20, 2023 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-cou... | Failed Impurities/Degradation Specifications | Class III | Glenmark Pharmaceuticals Inc., USA |
| 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 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 | 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, 1.25 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 |
| 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 | 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 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 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. |
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.