Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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DateProductReasonClassFirm
Sep 21, 2017 Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medlin... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mex... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by ... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medlin... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for ... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, ... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in M... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc.... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medli... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Pa... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline ... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for M... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Me... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., North... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingre... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfiel... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093 Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for ... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico ... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Pack... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in U... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Me... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexic... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Me... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medlin... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline ... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico f... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 15, 2017 Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by... Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which i... Class I Baxter Healthcare Corporation
Sep 15, 2017 ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v ... Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear)... Class II Becton Dickinson & Company
Sep 14, 2017 Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredien... CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pha... Class II Medisca, Inc.
Sep 13, 2017 Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in ... Failed Impurities/Degradation Specifications. Class III Vi-Jon, Inc.
Sep 13, 2017 Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in... Failed Impurities/Degradation Specifications. Class III Vi-Jon, Inc.
Sep 8, 2017 AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testo... Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. Class III AbbVie Inc.
Sep 8, 2017 AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Pa... Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. Class III AbbVie Inc.
Sep 5, 2017 Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Ph... Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is ... Class II Teva Pharmaceuticals USA
Aug 23, 2017 Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18... GMP Deviations; potential bacterial contamination may have been introduced to products through a ... Class II Inopak Ltd
Aug 17, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 m... Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substa... Class III VistaPharm, Inc.
Aug 16, 2017 Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz... Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... Class II Pharmatech LLC
Aug 10, 2017 Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Inj... Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds c... Class II Premier Pharmacy Labs 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.