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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Nov 13, 2017 | Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by:... | Failed Impurities/Degradation Specifications | Class III | Elite Laboratories Inc. |
| Nov 13, 2017 | 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Car... | Lack of Assurance of Sterility | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Nov 11, 2017 | Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 ... | Superpotent | Class III | Renaissance Lakewood, LLC |
| Nov 10, 2017 | Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx O... | Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of... | Class I | Baxter Healthcare Corporation |
| Nov 10, 2017 | Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spa... | Failed Stability Specifications | Class III | Bayer HealthCare Pharmaceuticals, Inc. |
| Nov 9, 2017 | Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distrib... | Failed Dissolution Specifications. | Class II | Mayne Pharma Inc |
| Nov 9, 2017 | GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118... | Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans | Class I | Kareway Products Inc |
| Nov 9, 2017 | Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Is... | Failed Tablet/Capsule Specifications; potential presence of broken tablets. | Class II | Teva Pharmaceuticals USA |
| Nov 8, 2017 | Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. ... | Microbial Contamination of Non-Sterile Products | Class II | L. Perrigo Company |
| Nov 6, 2017 | Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Via... | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 6, 2017 | Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, ... | Superpotent | Class III | Claris Lifesciences Inc |
| Nov 6, 2017 | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-... | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 3, 2017 | Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocai... | GMP Deviations: inadequate manufacturing control processes | Class II | Ridge Properties, LLC |
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.