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 |
|---|---|---|---|---|
| Oct 3, 2017 | Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CV... | Failed impurities/degradation specifications: Famotodine has an out of specification result for a... | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 2, 2017 | Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured ... | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was o... | Class II | Unichem Pharmaceuticals Usa Inc |
| Sep 28, 2017 | Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured b... | Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablet... | Class II | Leading Pharma, LLC |
| Sep 27, 2017 | FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bu... | Microbial Contamination of Non-Sterile Products | Class II | Pfizer Manufacturing Deutschland GmbH |
| Sep 27, 2017 | Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), ... | CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unk... | Class II | United Pharmacy |
| Sep 26, 2017 | HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg p... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx ... | Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. | Class II | The Harvard Drug Group |
| Sep 26, 2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL ... | Superpotent Drug | Class II | Pharmedium Services, LLC |
| Sep 25, 2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100... | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... | Class III | Amneal Pharmaceuticals, Inc. |
| Sep 25, 2017 | Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78... | Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap ... | Class III | Sandoz Inc |
| Sep 25, 2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-c... | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... | Class III | Amneal Pharmaceuticals, Inc. |
| Sep 25, 2017 | Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 6809... | Subpotent Drug: low out of specification results. | Class III | Precision Dose Inc. |
| Sep 25, 2017 | methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Co... | Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves u... | Class II | RXQ Compounding LLC |
| Sep 22, 2017 | Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist.... | Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incor... | Class III | Boehringer Ingelheim Pharmaceuticals, 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 |
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.