Browse Drug Recalls
1,528 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,528 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 1,528 FDA drug recalls in FL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 20, 2017 | Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-s... | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil. | Class I | Natures Supplement |
| 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. |
| Aug 30, 2017 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... | 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 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. |
| 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 | 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 17, 2017 | All Sterile Products within expiry | Lack of Assurance of Sterility . | Class II | Vital Rx, Inc. dba Atlantic Pharmacy and Compou... |
| Aug 17, 2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 m... | Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substa... | Class III | VistaPharm, Inc. |
| Aug 16, 2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 16, 2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, On... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 16, 2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 16, 2017 | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 10, 2017 | Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Inj... | Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds c... | Class II | Premier Pharmacy Labs Inc |
| Aug 7, 2017 | Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged fo... | Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with B... | Class I | International Laboratories, Inc. |
| Jun 26, 2017 | Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-uni... | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | Class II | VistaPharm, Inc. |
| Jun 26, 2017 | Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-... | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | Class II | VistaPharm, Inc. |
| Jun 6, 2017 | ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and... | Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. | Class I | Andropharm, LLC |
| Jun 6, 2017 | NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered s... | CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manu... | Class II | Bausch & Lomb, 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.