Browse Drug Recalls
2,002 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,002 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 2,002 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 16, 2017 | Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, K... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx On... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commer... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechno... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only,... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Oct 30, 2017 | Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, me... | Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt... | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 27, 2017 | Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2m... | Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Cont... | Class I | Fresenius Kabi USA, LLC |
| Oct 24, 2017 | Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by... | Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of... | Class II | Ace Surgical Supply Co., Inc. |
| Oct 13, 2017 | Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: T... | Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the i... | Class III | Sanofi-Aventis U.S. LLC |
| Oct 12, 2017 | Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, R... | Labeling: Incorrect or Missing Package Insert. | Class III | Genzyme Corporation |
| 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. |
| 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 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 | 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 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 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 |
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.