Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

20476–20500 of 39660

SevereFDA (Devices)·Z-2097-2017·2017-05-24
Ion Beam Applications Recalls Two Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling two Proteus 235 proton therapy systems in Florida because the device may restart irradiation from the beginning after a pause instead of recalculating the dose.
Product
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Category
Medical Device
Distribution
1 state
SevereFDA (Drugs)·D-0766-2017·2017-05-24
Key Pharmacy Recalls GSH/NAC Inhalation Solution Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling GSH/NAC inhalation solution because the firm cannot assure the product is sterile.
Product
GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0737-2017·2017-05-24
Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 200 vials of TRI MIX 10/30/0.5 injection due to a lack of assurance of sterility.
Product
TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0749-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Product
TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0714-2017·2017-05-24
Key Pharmacy Recalls DMPS Acid Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 214 vials of DMPS Acid injections because the firm cannot assure the sterility of the product.
Product
DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0758-2017·2017-05-24
Key Pharmacy Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Alpha Lipoic Acid injections due to a lack of assurance of sterility. The affected product was distributed in the U.S., Australia, and Canada.
Product
ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0763-2017·2017-05-24
Key Pharmacy Recalls Ferric Gluconate Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Ferric Gluconate Injection because the firm cannot guarantee the sterility of the compounded drug.
Product
FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0711-2017·2017-05-24
Key Pharmacy Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Atropine Sulfate 0.01% Ophthalmic Solution because the firm cannot assure the sterility of the product.
Product
ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0715-2017·2017-05-24
Key Pharmacy Recalls DMSO 6.25% Ophthalmic Solution Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling DMSO 6.25% Ophthalmic Solution because the firm cannot ensure the product is sterile.
Product
DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0767-2017·2017-05-24
Key Pharmacy Recalls GSH/NAC Inhalation Solution Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling GSH/NAC Inhalation Solution due to a lack of assurance of sterility.
Product
GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0755-2017·2017-05-24
Key Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Quad Mix 50/30/1/0.2 injection because the firm cannot assure the sterility of the product.
Product
QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0783-2017·2017-05-24
Key Pharmacy Recalls Testosterone Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Injection due to a lack of assurance of sterility.
Product
TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0740-2017·2017-05-24
FDA Recalls Key Pharmacy Compounded Sterile Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Product
TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0756-2017·2017-05-24
Key Pharmacy Recalls PGE1/Procaine Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injections because the firm cannot guarantee the products are sterile.
Product
PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0725-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the compounded drugs.
Product
HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0709-2017·2017-05-24
Key Pharmacy Recalls 5-MTHF Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL single-dose vials because the firm cannot assure the sterility of the product.
Product
5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0720-2017·2017-05-24
Key Pharmacy Recalls HCG Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 72 vials of HCG injections because the firm cannot assure the sterility of the compounded drugs.
Product
HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0773-2017·2017-05-24
Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Procaine HCL 1% injections because the firm cannot assure the sterility of the compounded drugs.
Product
PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0774-2017·2017-05-24
Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 2% injections because the firm cannot guarantee the products are sterile.
Product
PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0707-2017·2017-05-24
Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 5-MTHF injections because the firm cannot assure the products are sterile.
Product
5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1926-2017·2017-05-24
Magellan LeadCare Ultra Blood Lead Test Kits Recalled for Inaccurate Results
Magellan Diagnostics is recalling LeadCare Ultra Blood Lead Test Kits because they may generate falsely low lead concentrations when used with specific Becton Dickinson EDTA Vacutainer tubes.
Product
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0717-2017·2017-05-24
Key Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 20 vials of Folic Acid 10mg/mL injection due to a lack of assurance of sterility.
Product
FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0777-2017·2017-05-24
Key Pharmacy Recalls Pyridoxal-5-Phosphate Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Pyridoxal-5-Phosphate 50mg/mL injection vials due to a lack of assurance of sterility.
Product
PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1925-2017·2017-05-24
Magellan LeadCare Blood Analyzer Recall for Falsely Low Lead Results
Magellan Diagnostics is recalling LeadCare Ultra Blood Analyzers because they may generate falsely low lead concentrations when used with specific Becton Dickinson collection tubes.
Product
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0727-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.
Product
HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide

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20476–20500 of 39660