Browse Drug Recalls

1,527 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,527 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 1,527 FDA drug recalls in FL.

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DateProductReasonClassFirm
Jul 30, 2025 Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Calcium Chloride for Injection, all strengths and presentations, GenoGenix, L... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL mu... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, ... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Magnesium Chloride for Injection, all strengths and presentations, GenoGenix,... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoG... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 N... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 30, 2025 Reconstitution XO Solution for Injection, all strengths and presentations, Ge... Lack of Assurance of Sterility Class II GenoGenix LLC
Jul 2, 2025 Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle,... Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 i... Class II Lupin Pharmaceuticals Inc.
Jun 27, 2025 clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelica... Failed Impurities/Degradation Specifications: an out of specification result observed in degradat... Class II Lupin Pharmaceuticals Inc.
Jun 20, 2025 Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles... Product Mix Up: This product is being recalled because of a complaint received that a sealed bott... Class II Lupin Pharmaceuticals Inc.
May 28, 2025 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, R... Lack of Assurance of Sterility Class II Apotex Corp.
May 28, 2025 Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Ap... Defective Container: This recall is being initiated due to a leaking unit stored horizontally. Class II Apotex Corp.
May 28, 2025 Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. ... Lack of Assurance of Sterility Class II Apotex Corp.
May 28, 2025 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufacture... Lack of Assurance of Sterility Class II Apotex Corp.
Apr 10, 2025 clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Ma... Failed Impurities/Degradation Specifications: an out of specification result observed in degradat... Class II Lupin Pharmaceuticals Inc.
Feb 13, 2025 Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid... Defective Container: broken or leaking bottles. Class II World Perfumes Inc.
Dec 10, 2024 PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles,... Lack of Sterility Assurance Class II Regenerative Processing Plant, LLC
Dec 10, 2024 LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distribu... Lack of Sterility Assurance Class II Regenerative Processing Plant, LLC
Oct 31, 2024 Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 ... Defective Delivery System: The product does not meet predetermined specifications for Coldflow (a... Class II Noven Pharmaceuticals Inc
Aug 20, 2024 Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g... LABELING: LABEL MIX-UP. Class III Elevate Oral Care
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by:... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed b... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz ... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 20, 2024 Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) pa... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as ... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Package... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) P... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packag... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UP... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL ... CGMP deviations Class II Little Moon Essentials LLC
Apr 24, 2024 Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual... Presence of Foreign Substance; Broken metal piece found embedded in tablet. Class II Coast Quality Pharmacy, LLC dba Anazao Health
Apr 22, 2024 Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, dis... Marketed Without An Approved NDA/ANDA Class I Stop Clopez Corp
Feb 16, 2024 Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine ma... Stability testing failures for one or two of the four active pharmaceutical ingredients among the... Class II Global Corporation
Feb 16, 2024 Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine H... Stability testing failures for one or two of the four active pharmaceutical ingredients among the... Class II Global Corporation
Feb 9, 2024 Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net ... CGMP Deviations: potential presence of Burkholderia cepacia complex Class II Apotex Corp.
Jan 19, 2024 Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS CGMP Deviations Class II OMEZA LLC
Jan 19, 2024 Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials CGMP Deviations Class II OMEZA LLC
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Oct 26, 2023 Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, M... Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution wi... Class III VistaPharm 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.