Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 22, 2013 | Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Nora Apothecary and Alternative Therapies, Inc. |
| Apr 22, 2013 | Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Nora Apothecary and Alternative Therapies, Inc. |
| Apr 22, 2013 | HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Nora Apothecary and Alternative Therapies, Inc. |
| Apr 19, 2013 | Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluro... | Non-Sterility | Class I | Abrams Royal Pharmacy |
| Apr 17, 2013 | Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a divisi... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible ... | Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopene... | Class II | Unique Pharmaceutical, Ltd |
| Apr 17, 2013 | Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy ... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compoundi... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compo... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a divisio... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy ... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compou... | Lack of Sterility Assurance | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharma... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pha... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Ph... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Ax... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmac... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharma... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a d... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a di... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharm... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, ... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compoun... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmac... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a divisio... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Comprehensive injection #4 - SS varied injectable Injectable Balanced Soluti... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 17, 2013 | Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmac... | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... | Class II | Axium Healthcare Pharmacy dba Balanced Solution... |
| Apr 15, 2013 | The firm is recalling all lots of sterile products compounded by the pharmacy... | Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assura... | Class II | Apothecure, Inc |
| Apr 15, 2013 | HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVisio... | Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... | Class I | NuVision Pharmacy, Inc. |
| Apr 15, 2013 | Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVisio... | Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assuranc... | Class I | NuVision Pharmacy, Inc. |
| Apr 10, 2013 | Medroxyprogesterone Acetate Injection, all strengths and all presentations in... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | MIC Vitamin Injection, all strengths and all presentations including a) MIC 2... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Methylprednisolone and Dexamethasone Injection, all strengths and all present... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Bacteriostatic Water for Injection, all presentations including 30 mL, Rx onl... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Buprenorphine Injection, all strengths and all presentations including Bupren... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Testosterone Cypionate and Testosterone Propionate Injection, all strengths a... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Bupivacaine Injection, all strengths and all presentations including a) Bupiv... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Dexamethasone Sodium Phosphate Injection, all strengths and all presentations... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Taurine Injection, all strengths and all presentations including a) Taurine 5... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Magnesium Sulfate Injection, all strengths and all presentations including a)... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Bupivacaine and Dexamethasone Injection, all strengths and all presentations ... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Ascorbic Acid Injection, all strengths and all presentations including a) 500... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Estradiol Valerate Injection, all strengths and all presentations including a... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Methylprednisolone and Bupivacaine Injection, all strengths and all presentat... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Methylprednisolone Acetate and Marcaine Injection, all strengths and all pres... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
| Apr 10, 2013 | Testosterone Cypionate Injection, all strengths and all presentations includi... | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by t... | Class II | FVS Holdings, Inc. dba. Green Valley Drugs |
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.