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.

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DateProductReasonClassFirm
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.