Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

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.

Clear
DateProductReasonClassFirm
Jun 21, 2019 Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain ... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Pheny... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 18, 2019 Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, ... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), ... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL St... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premie... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SD... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Ba... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SD... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50m... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syri... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premie... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Sing... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 17, 2019 Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g bo... Failed Stability Specifications: Out of specification for viscosity. Class III Bausch & Lomb
May 2, 2019 DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar P... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guai... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorph... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pin... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moi... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Si... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fe... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg ... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 P... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Apr 19, 2019 BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biol... Defective Delivery System: difficult to express Class II Pacifico National, Inc. dba AmEx Pharmacy
Mar 18, 2019 Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx O... Defective Container: firm discovered samples stored horizontally as well as product quality compl... Class III Ingenus Pharmaceuticals Llc
Jan 16, 2019 NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Jan 16, 2019 NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Jan 8, 2019 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Hap... Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... Class I Happy Together, Inc.
Dec 17, 2018 Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compoundin... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Ph... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promi... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialis... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide De... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy C... Lack of sterility assurance. Class II Promise Pharmacy, 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.