Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 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 | 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 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 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 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 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 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 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 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 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 | 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 | 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 | 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 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 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 | 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 11, 2017 | TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg... | CGMP Deviations | Class II | United Therapeutics Corp. |
| Sep 5, 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. ... | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz.... | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| 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 |
| Sep 5, 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz.... | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Steri... | Lack of Assurance of Sterility and cGMP Deviations | Class II | Simple Diagnostics, Inc. |
| Sep 5, 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. ... | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Sali... | Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for ... | Class II | Llorens Pharmaceutical Corp. |
| Sep 1, 2017 | Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL b... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx On... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 ... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx O... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL b... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx On... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactu... | Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials. | Class II | Pfizer Inc. |
| Sep 1, 2017 | Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx On... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL b... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Onl... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 1, 2017 | Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... | Subpotent Drug | Class II | Pharmedium Services, LLC |
| Aug 31, 2017 | Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Si... | Presence of Particulate Matter | Class II | Amneal Pharmaceuticals LLC |
| Aug 30, 2017 | Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochlori... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Mid Valley Pharmaceutical |
| Aug 30, 2017 | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... | Defective Delivery System: Products no longer meet the release liner removal specification and/or... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 30, 2017 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... | Defective Delivery System: Products no longer meet the release liner removal specification and/or... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 30, 2017 | Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephri... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Mid Valley Pharmaceutical |
| Aug 30, 2017 | Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.... | Defective Delivery System: Products no longer meet the release liner removal specification and/or... | Class II | Noven Pharmaceuticals, 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.