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 |
|---|---|---|---|---|
| Oct 19, 2013 | VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Comp... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
| Oct 19, 2013 | Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compoundi... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
| Oct 19, 2013 | Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medici... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
| Oct 19, 2013 | Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compou... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
| Oct 19, 2013 | FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only... | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... | Class II | Specialty Medicine Compounding Pharmacy |
| Oct 18, 2013 | Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 260... | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... | Class II | Compounding Centre At Blue Ridge |
| Oct 18, 2013 | PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compou... | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... | Class II | Compounding Centre At Blue Ridge |
| Oct 18, 2013 | Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Su... | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... | Class II | Compounding Centre At Blue Ridge |
| Oct 18, 2013 | Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr B... | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... | Class II | Compounding Centre At Blue Ridge |
| Oct 18, 2013 | Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compo... | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... | Class II | Compounding Centre At Blue Ridge |
| Oct 11, 2013 | 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fli... | Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. | Class II | Hospira Inc. |
| Oct 2, 2013 | Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalatio... | Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic ... | Class II | Nephron Pharmaceuticals Corp. |
| Sep 16, 2013 | Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage ... | Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the ... | Class II | Hospira, Inc. |
| Sep 11, 2013 | Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only J... | Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a steril... | Class II | Janssen Pharmaceuticals, Inc. |
| Sep 9, 2013 | Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 8... | Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin... | Class II | Avella of Deer Valley, Inc. |
| Sep 9, 2013 | Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085... | Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin... | Class II | Avella of Deer Valley, Inc. |
| Sep 6, 2013 | Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL ... | Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... | Class II | University Compounding Pharmacy |
| Sep 6, 2013 | Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, Universit... | Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... | Class II | University Compounding Pharmacy |
| Sep 6, 2013 | SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apot... | Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent ... | Class II | Apothecary Shoppe |
| Sep 6, 2013 | Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL ... | Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro... | Class II | Triangle Compounding |
| Sep 6, 2013 | Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottl... | Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact ... | Class I | Altaire Pharmaceuticals, Inc. |
| Sep 6, 2013 | PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Ph... | Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... | Class II | University Compounding Pharmacy |
| Sep 6, 2013 | Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, ... | Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro... | Class II | Triangle Compounding |
| Sep 6, 2013 | PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding P... | Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... | Class II | University Compounding Pharmacy |
| Sep 6, 2013 | Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The... | Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent ... | Class II | Apothecary Shoppe |
| Sep 6, 2013 | Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Comp... | Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain ... | Class II | University Compounding Pharmacy |
| Sep 5, 2013 | Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern Sta... | Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL ... | Class II | Northern New England Compounding Pharmacy LLC |
| Sep 5, 2013 | Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL s... | Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility ass... | Class II | Fallon Wellness Pharmacy Llc |
| Sep 5, 2013 | 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial,... | Lack of Assurance of Sterility; potential for vial breakage | Class II | Hospira Inc. |
| Aug 26, 2013 | Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Co... | Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... | Class II | Leiter's Pharmacy |
| Aug 26, 2013 | Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose via... | Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... | Class II | Leiter's Pharmacy |
| Aug 26, 2013 | Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vi... | Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... | Class II | Leiter's Pharmacy |
| Aug 26, 2013 | Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations... | Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection... | Class II | Pharmacy Creations |
| Aug 26, 2013 | Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Le... | Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... | Class II | Leiter's Pharmacy |
| Aug 26, 2013 | EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Cr... | Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection... | Class II | Pharmacy Creations |
| Aug 23, 2013 | Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Fre... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | JCB Labs LLC |
| Aug 23, 2013 | Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-2... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, In... | Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone... | Class II | Walgreens Co |
| Aug 23, 2013 | Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Inje... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | JCB Labs LLC |
| Aug 23, 2013 | Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile... | Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace... | Class II | South Coast Specialty Compounding, Inc. |
| Aug 23, 2013 | Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL... | Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace... | Class II | South Coast Specialty Compounding, Inc. |
| Aug 23, 2013 | Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | JCB Labs LLC |
| Aug 23, 2013 | Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | Medaus, Inc. |
| Aug 23, 2013 | RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELL... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | Medaus, Inc. |
| Aug 23, 2013 | Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 3... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | JCB Labs LLC |
| Aug 23, 2013 | Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS ... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183 | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | Medaus, Inc. |
| Aug 23, 2013 | Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMAC... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vial... | Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcoba... | Class II | South Coast Specialty Compounding, 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.