Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 15, 2019 | Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Inc... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio ... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Inc... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpora... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 10, 2019 | Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx On... | Lack of Sterility Assurance. | Class II | Innoveix Pharmaceuticals Inc |
| Oct 10, 2019 | Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx On... | Lack of Sterility Assurance. | Class II | Innoveix Pharmaceuticals Inc |
| Oct 10, 2019 | Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: I... | Lack of Sterility Assurance. | Class II | Innoveix Pharmaceuticals Inc |
| Oct 10, 2019 | Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, ... | Lack of Sterility Assurance. | Class II | Innoveix Pharmaceuticals Inc |
| Oct 9, 2019 | del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephr... | Lack of Assurance of Sterility; bags have potential to leak | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 9, 2019 | Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysi... | Lack of Assurance of Sterility; bags have potential to leak | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 2, 2019 | 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 ... | Lack of Assurance of Sterility: Bag has the potential to leak. | Class II | Pfizer Inc. |
| Oct 1, 2019 | Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injectio... | Lack of sterility assurance. | Class II | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy |
| Sep 20, 2019 | Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx ... | Lack of Assurance of Sterility: Out of specification results for container closure test which can... | Class II | Akorn, Inc. |
| Sep 18, 2019 | Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: ... | Lack of sterility assurance. | Class II | Avella of Deer Valley, Inc. Store 38 |
| 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 | Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized,... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 2... | 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 | Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injection... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), F... | 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 | 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 | 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 | 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 | Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Sin... | 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 | 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 | 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 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 ... | 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 | Sermorelin Acetate 9 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 | Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Onl... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg... | 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 | 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 | Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx... | 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 | 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 | 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 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 | 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 |
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.