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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 12, 2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL S... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Par... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syr... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnolog... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL)... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single D... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free)... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 1... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only,... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 10... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Us... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 10... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropic... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx On... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxin... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KR... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 2... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS G... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Sy... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global B... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechno... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Ca... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.01... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite F... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Sing... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Gl... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Us... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropic... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Sing... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx O... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 6, 2019 | Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g N... | Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified a... | Class I | Darmerica, 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.