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 |
|---|---|---|---|---|
| Jan 26, 2018 | Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured ... | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... | Class I | Primus Pharmaceuticals, Inc. |
| Jan 26, 2018 | Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured ... | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... | Class I | Primus Pharmaceuticals, Inc. |
| Jan 22, 2018 | Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Mar... | Labeling: Label Error on Declared Strength | Class II | Astellas Pharma US Inc |
| Jan 22, 2018 | Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manuf... | Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol | Class III | Ascent Pharmaceuticals, Inc. |
| Jan 17, 2018 | Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured ... | Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative conta... | Class I | Magno Humphries Laboratories, Inc |
| Jan 11, 2018 | Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounde... | Labeling: Label Error on Declared Strength | Class II | Premier Pharmacy Labs Inc |
| Jan 4, 2018 | Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: In... | LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogr... | Class I | International Laboratories, LLC |
| Dec 7, 2017 | Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syring... | Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and bey... | Class II | SCA Pharmaceuticals |
| Dec 5, 2017 | Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count ... | Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found p... | Class III | Sanofi-Aventis U.S. LLC |
| Dec 4, 2017 | Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/... | Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg | Class II | Solco Healtcare US LLC |
| Nov 20, 2017 | Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28... | Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil a... | Class II | Teva Pharmaceuticals USA |
| Nov 16, 2017 | Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Bi... | 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 | Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, 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 | Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of ... | 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 | 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Globa... | 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 #16, 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 | Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, 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 | T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For... | 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 8%, Tetracaine 4% Topical Cream packaged in jars, R... | 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 | Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global B... | 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 | Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mes... | 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 500 iu Orally Disintegrating Tablets (ODT), Rx O... | 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 20,000 iu/Vial, Lyophilized - For SC Use, Rx Onl... | 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 5,000 iu/ Vial Lyophilized, For SC Use, 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 | Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx... | 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 | 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Comm... | 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 | Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology,... | 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 11,000 iu/Vial Lyophilized For SC Use, 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 | Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder pa... | 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 | Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnol... | 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 | PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Com... | 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 | Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusi... | 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 | Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnol... | 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 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.... | 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 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder... | 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 | Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged... | 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 | Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC U... | 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 | Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 79... | 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 | Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For I... | 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 | Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged ... | 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 | Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesy... | 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 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0... | 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 | Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, 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 | QUADMIX #17, 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 | Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 P... | 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 | Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of C... | 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 | Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology... | 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 | Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotec... | 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 | Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, 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 | Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream package... | 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 |
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.