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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
Dec 17, 2018 Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialis... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pha... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compo... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Com... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise P... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Ph... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compou... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compound... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy C... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialist... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Pro... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compoun... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compound... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%,... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialist... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcob... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compoundin... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.0... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy C... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thi... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Speci... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compo... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compound... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Com... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Nov 30, 2018 NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged... Failed Impurities/Degradation Specifications:Out of specification for impurities. Class III VistaPharm, Inc.
Nov 6, 2018 Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Di... Failed Stability Specifications: Out-of-Specification results obtained for particle size distribu... Class III Breckenridge Pharmaceutical, Inc.
Oct 18, 2018 Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bott... Presence of precipitate Class III Promise Pharmacy LLC
Oct 15, 2018 Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sa... Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine Class II Zero Xtreme USA
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 ... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Aug 10, 2018 Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville... Incorrect Product Formulation Class II Westlab Pharmacy, Inc. dba Westlab Pharmacy
Aug 10, 2018 ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tro... Lack of Process Controls Class II Westlab Pharmacy, Inc. dba Westlab Pharmacy
Aug 10, 2018 Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 3260... Lack of Process Controls Class II Westlab Pharmacy, Inc. dba Westlab Pharmacy
Aug 3, 2018 CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing 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.