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.

Clear
DateProductReasonClassFirm
May 31, 2024 Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of ho... Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferr... Class III Washington Homeopathic Products, Inc.
May 28, 2024 Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... Defective Container Class III Organon Llc
May 28, 2024 Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... Defective Container Class III Organon Llc
May 28, 2024 Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati... Defective Container Class III Organon Llc
May 22, 2024 Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mf... Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide... Class III Eugia US LLC
May 17, 2024 Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, ... Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*,... Class III GlaxoSmithKline LLC
May 16, 2024 Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manuf... Failed Impurities/Degradation Specifications. Class III Zydus Pharmaceuticals (USA) Inc
May 16, 2024 Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Risin... Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Pack... Class III Rising Pharma Holding, Inc.
May 16, 2024 Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufa... Failed Impurities/Degradation Specifications. Class III Zydus Pharmaceuticals (USA) Inc
May 10, 2024 Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Rel... Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on ... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), ... Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed),... Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixe... Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixe... Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 1, 2024 Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. ... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Apr 30, 2024 Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged... Labeling: Wrong Barcode Class III Hikma Injectables USA Inc
Apr 25, 2024 Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for... Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing ... Class III Viatris Inc
Apr 24, 2024 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle... Subpotent drug Class III Acella Pharmaceuticals, LLC
Apr 22, 2024 Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle... Failed Release Testing: Out of specification for particulate matter test. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Apr 10, 2024 Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL S... Out of specification for assay Class III Imprimis NJOF, LLC
Apr 9, 2024 Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 5... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, ... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 2, 2024 Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Apr 2, 2024 Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, ... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
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 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 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 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.
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.
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 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 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 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

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.