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 |
|---|---|---|---|---|
| May 9, 2022 | Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Ph... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only,... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Package... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympi... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 670... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceutica... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceu... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceutic... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceut... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Ol... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharma... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuti... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceu... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Package... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuti... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olymp... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 6, 2022 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... | Defective Delivery System: customer complaints exceeded respective action limits. | Class II | Noven Pharmaceuticals Inc |
| May 3, 2022 | Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... | Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... | Class III | Apotex Corp. |
| Apr 4, 2022 | BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, R... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dos... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution,... | Failed Reconstitution time | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Mu... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmac... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Pa... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . A... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile ... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Apr 4, 2022 | T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Pa... | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... | 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.