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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 18, 2023 | Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottle... | Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. | Class I | VistaPharm LLC |
| Oct 17, 2023 | Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz... | Failed Excipient Specifications: high content of ethylene glycol (EG) | Class III | VistaPharm LLC |
| Oct 16, 2023 | THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blis... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenaf... | Class I | Noah's Wholesale LLC |
| Aug 30, 2023 | Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL ... | Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results | Class II | VistaPharm LLC |
| Aug 3, 2023 | Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (In... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenaf... | Class I | APG SEVEN, INC |
| Aug 2, 2023 | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B.... | Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructi... | Class III | B. Braun Medical Inc. |
| Jul 5, 2023 | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B.... | Lack of assurance of sterility: bags have the potential to leak. | Class II | B. Braun Medical Inc. |
| Apr 26, 2023 | Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon ... | Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat render... | Class II | Apotex Corp. |
| Apr 7, 2023 | Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For... | CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inven... | Class II | Methapharm Inc |
| Mar 10, 2023 | Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx ... | Defective Delivery System: Out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Mar 10, 2023 | Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx... | Defective Delivery System: Out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Mar 10, 2023 | Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx ... | Defective Delivery System: Out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Mar 10, 2023 | Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx... | Defective Delivery System: Out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Mar 1, 2023 | Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL... | Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartr... | Class II | Apotex Corp. |
| Feb 15, 2023 | Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One... | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Feb 15, 2023 | Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One... | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Feb 10, 2023 | 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B... | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... | Class II | B. Braun Medical Inc. |
| Feb 10, 2023 | 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B.... | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... | Class II | B. Braun Medical Inc. |
| Dec 21, 2022 | Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apote... | Failed Stability Specifications: Out of specification for weight loss at the 18-month stability t... | Class III | Apotex Corp. |
| Dec 1, 2022 | Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syr... | Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained pro... | Class I | BayCare Integrated Service Center, LLC /dba Bay... |
| Nov 16, 2022 | Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (... | Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is ... | Class II | Noven Pharmaceuticals Inc |
| Nov 9, 2022 | Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Cont... | CGMP deviations | Class II | DISCOVERY PHARMA LLC |
| Sep 30, 2022 | Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured ... | Out of specification for related substances (impurities). | Class II | Ingenus Pharmaceuticals Llc |
| Sep 30, 2022 | Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged ... | cGMP Deviations: Out of specification for assay of one of the preservative ingredients. | Class II | VistaPharm, Inc. |
| Sep 14, 2022 | Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottl... | GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification... | Class II | Salon Technologies International Inc |
| Sep 14, 2022 | Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) ... | Chemical Contamination: product found to contain benzene | Class I | Salon Technologies International Inc |
| Jul 22, 2022 | SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack wi... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil. | Class I | Distributor RFR, LLC. |
| Jul 7, 2022 | Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 6050... | Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. | Class II | Apotex Corp. |
| Jun 24, 2022 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... | Defective Delivery System: Customer complaints received for ripping patches and tight release/adh... | Class II | Noven Pharmaceuticals Inc |
| May 9, 2022 | Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 m... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceut... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dos... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Mangan... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamin... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pha... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Ol... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atro... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmac... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL R... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanoba... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, package... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia P... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia 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.