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 |
|---|---|---|---|---|
| Jan 15, 2016 | Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx i... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's C... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 5, 2016 | Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and... | Lack of Assurance of Sterility: Failed preservative effectiveness test | Class II | Mayne Pharma Usa |
| Dec 29, 2015 | Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous adm... | Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture. | Class I | Complete Pharmacy and Medical Solutions LLC |
| Dec 29, 2015 | Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, ... | Lack of assurance of sterility | Class II | TexasStar Pharmacy |
| Dec 24, 2015 | IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syr... | Lack of Assurance of Sterility | Class II | Amerita Specialty Infusion Services |
| Dec 24, 2015 | Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Comp... | Lack of Assurance of Sterility | Class II | Amerita Specialty Infusion Services |
| Nov 10, 2015 | 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 14... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Car... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, Sa... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Com... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Ca... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS ... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, Sa... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, ... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compou... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compound... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San A... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compo... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San ... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL,... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounde... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, R... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148,... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | 0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx On... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, ... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option C... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL ... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, C... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San A... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 1... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, ... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, R... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, S... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Oct 19, 2015 | Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Stree... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springe... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springervi... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springervi... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Spr... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug ... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerv... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Stree... | Lack of Assurance of Sterility | Class II | Western Drug |
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.