Browse Drug Recalls
1,536 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,536 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 1,536 FDA drug recalls in FL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 13, 2026 | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx o... | Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance c... | Class II | Apotex Corp. |
| Aug 3, 2026 | Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for:... | Failed content uniformity specifications. | Class II | Lupin Pharmaceuticals Inc. |
| Jun 23, 2026 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg p... | CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 4, 2026 | prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 m... | Presence of Foreign Substance | Class II | Lupin Pharmaceuticals Inc. |
| Jun 4, 2026 | Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care,... | sub potency | Class II | Elevate Oral Care |
| May 14, 2026 | Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distribu... | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, ex... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Apr 24, 2026 | Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin... | Presence of particulate matter: a white thread-like structure in the cartridge | Class II | Lupin Pharmaceuticals Inc. |
| Apr 8, 2026 | Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only... | Defective container: defect in a batch of bottle caps, specifically involving dislodged or missin... | Class II | Apotex Corp. |
| Mar 5, 2026 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx... | Lack of Assurance of Sterility | Class II | Apotex Corp. |
| Feb 2, 2026 | Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4... | cGMP deviations | Class II | Pro Numb Tattoo Numbing Spray LLC |
| Feb 2, 2026 | Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL]... | cGMP deviations | Class II | Pro Numb Tattoo Numbing Spray LLC |
| Nov 13, 2025 | Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syr... | Failed impurities/degradation specifications: out of specification results for Ganirelix acetate ... | Class II | Lupin Pharmaceuticals Inc. |
| Nov 5, 2025 | Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Ma... | Defective container - seal not adhering to bottles | Class II | Lupin Pharmaceuticals Inc. |
| Sep 5, 2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Man... | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... | Class II | Apotex Corp. |
| Sep 5, 2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL ... | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... | Class II | Apotex Corp. |
| Jul 30, 2025 | Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 28... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Semaglutide with B12 for Injection, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Sterile Saline Reconstitution Solution for Injection, all strengths and prese... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL M... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Low Solubility Peptide Reconstitution Solution for Injection, all strengths a... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and present... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 m... | Microbial Contamination of Sterile Products: elevated endotoxin levels | Class I | GenoGenix LLC |
| Jul 30, 2025 | Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 284... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Elite Stack Reconstitution Solution for Injection, all strengths and presenta... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | pH Buffered Reconstitution Solution for Injection, all strengths and presenta... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, Geno... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LL... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGe... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Glutathione Preserved for Injection, all strengths and presentations, GenoGen... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Glutathione Magnesium for Injection, all strengths and presentations, GenoGen... | Lack of Assurance of Sterility | Class II | GenoGenix 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.