Browse Drug Recalls
1,141 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,141 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 1,141 FDA drug recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 20, 2017 | Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in ... | Lack of Assurance of Sterility | Class II | Deserving Health International Corp |
| Sep 20, 2017 | Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceutical... | Cross contamination with other products: traces of Dapsone were found in the finished product. | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Sep 20, 2017 | Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-s... | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil. | Class I | Natures Supplement |
| Sep 15, 2017 | RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packet... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distribute... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, 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 | FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, ... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| 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 15, 2017 | grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana See... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| 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 | Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1... | Presence of particulate matter: glass flakes identified as lamellae observed during a routine qua... | Class II | Amgen, 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 | Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distribute... | Failed Stability 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 11, 2017 | TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg... | CGMP Deviations | Class II | United Therapeutics Corp. |
| 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. |
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.