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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
Jun 6, 2017 ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsu... Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. Class I Andropharm, LLC
May 17, 2017 Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60m... Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved ... Class III VistaPharm, Inc.
Apr 27, 2017 Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems pe... Defective Delivery System: Out of specification for peel force from the release liner specificati... Class III Noven Pharmaceuticals, Inc.
Mar 1, 2017 Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectr... Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial conta... Class II Signature Club A Ltd
Jan 18, 2017 Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (3... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 l... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15... Defective Container: Leakage of unit dose cups that may occur at the seal. Class II VistaPharm, Inc.
Jan 18, 2017 Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per ca... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottl... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL pe... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 5, 2017 Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swi... Subpotent Class III InnovaGel
Jan 5, 2017 Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, ... Subpotent Class III InnovaGel
Dec 14, 2016 Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex I... CGMP Deviations Class II Apotex Corp.
Dec 14, 2016 Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex In... CGMP Deviations Class II Apotex Corp.
Nov 17, 2016 Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Cholin... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy. Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 m... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Dexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL, (1 ML). Compo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). C... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-C... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/m... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Com... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/M... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy. Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML an... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Glutamine 25 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 L-Tyrosine 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-C... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by T... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coa... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL, (1 ML). Comp... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxin... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy

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.