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
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
Aug 3, 2017 Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g)... Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jel... Class II MEDLINE INDUSTRIES INC
Sep 25, 2015 ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle,... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I Medline Industries Inc
Sep 25, 2015 ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottl... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I 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.