Browse Drug Recalls

77 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 77 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 77 FDA drug recalls.

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DateProductReasonClassFirm
Nov 8, 2021 Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, ND... Defective Container: Customer complaints for leaking bottles and dispensing issues. Class II Medline Industries Inc
May 14, 2021 READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) D... Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate. Class III Medline Industries Inc
Dec 7, 2018 Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) pa... GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif... Class II US Pharmaceuticals Inc.
Sep 17, 2018 SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g t... Microbial Contamination of Non-Sterile Product Class II Medline Industries Inc
May 22, 2018 READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloth... Microbial Contamination of a Non-Sterile Product. Class II Medline Industries Inc (Northpoint Services)
Feb 15, 2018 PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodi... Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. Class II Medline Industries Inc
Sep 21, 2017 Medline All Purpose Instrument Tray, Sterile. 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 Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. D... 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 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 Straight Suture Removal 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 GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA fo... 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 Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico b... 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 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 General Purpose 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 NICC Suture Removal Tray, 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 Skin Staple Remover Kit, 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 Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Med... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged... 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 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 Laceration Tray, Sterile, Single Use Only. Packaged in USA 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 Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Indust... 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 Pacemaker Implant Pack, 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 Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA f... 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 Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Med... 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 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 Staple Remover 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 CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industrie... 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 CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contai... 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 Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Indus... 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 Circumcision Tray Kit, 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 21, 2017 Medline Sheath 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 Trunk Kit, Non-sterile. 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 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

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.