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

14501–14525 of 18001

CriticalFDA (Drugs)·D-470-2015·2015-04-15
Central Admixture Pharmacy Services Recalls TPN Neonatal Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling 12 bags of Virginia Hospital Center TPN Neonatal Day 1 Bags due to out-of-specification sterility test results indicating microbial contamination.
Product
Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-459-2015·2015-04-15
CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of a neonatal IV infusion compound because sterility testing failed.
Product
Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine 5%, Dextrose 5%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-465-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Non-Sterile TPN Infusion Bags
Central Admixture Pharmacy Services is recalling 3 bags of compounded TPN infusion bags due to non-sterility test failures.
Product
Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-453-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Neonate TPN Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling six bags of neonate TPN starter bags due to out-of-specification sterility test results indicating microbial contamination.
Product
Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-460-2015·2015-04-15
FDA Recalls 20 Neonatal TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling 20 neonatal TPN bags because sterility tests showed microbial contamination.
Product
Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 200mg/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-462-2015·2015-04-15
Central Admixture Pharmacy Services Recalls TPN Neonatal Starter Bags
Central Admixture Pharmacy Services is recalling TPN Neonatal Starter IV infusion bags due to out-of-specification sterility test results.
Product
Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-449-2015·2015-04-15
FDA Recalls Non-Sterile Neonatal TPN Bags Due to Microbial Contamination
Central Admixture Pharmacy Services is recalling 10 bags of neonatal TPN due to failed sterility tests indicating microbial contamination.
Product
Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-440-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Neonate D5 Bridge IV Infusion Bags
Central Admixture Pharmacy Services is recalling two bags of a neonatal IV infusion bag due to out-of-specification sterility test results.
Product
Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-442-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags
Central Admixture Pharmacy Services is recalling four bags of neonatal TPN solution due to failed sterility tests indicating microbial contamination.
Product
Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-455-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Non-Sterile TPN Infusion Bags
Central Admixture Pharmacy Services is recalling five bags of Truman Medical Center Lakewood Starter TPN due to out-of-specification sterility test results indicating microbial contamination.
Product
Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 10%, Additives: Calcium Gluconate 4.8mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-450-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags
Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to non-sterility test failures. The product was distributed nationwide.
Product
Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-438-2015·2015-04-15
Central Admixture Pharmacy Services Recalls TPN Neonate Starter Bags for Sterility Issues
Central Admixture Pharmacy Services is recalling 10 bags of TPN Neonate Starter Bags due to out-of-specification sterility test results indicating microbial contamination.
Product
Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0433-2015·2015-04-15
Hospira Recalls MitoXANTRONE Injection Due to Stability Failures
Hospira Inc. is recalling MitoXANTRONE Injection vials because the product failed stability specifications, resulting in subpotent medication and out-of-specification impurities.
Product
MITOXANTRONE — MITOXANTRONE (MITOXANTRONE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-445-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Compounded TPN Infusion Bags
Central Admixture Pharmacy Services is recalling 4 bags of compounded TPN infusion bags due to non-sterility test failures.
Product
Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-447-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Compounded TPN Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling three bags of compounded TPN due to out-of-specification sterility test results indicating microbial contamination.
Product
Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF 100 units/mL, 50 units/dL, Calcium Gluconate 0.46 mEq/mL, 200 mg/dL, compound vol: 300 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-457-2015·2015-04-15
FDA Recalls Non-Sterile Compounded Neonatal IV Infusion Bags
Central Admixture Pharmacy Services is recalling 10 bags of compounded neonatal IV solution due to sterility test failures.
Product
Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-481-2015·2015-04-15
Baxter Recalls Sodium Chloride Injection Bags Due to Plastic Fragments
Baxter Healthcare is recalling 542,080 bags of 0.9% Sodium Chloride Injection USP due to confirmed reports of blue plastic fragments from vial adapters.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0434-2015·2015-04-15
Wallcur Recalls Practi-0.9% Sodium Chloride Bags Due to Non-Sterility
Wallcur Incorporated is recalling Practi-0.9% Sodium Chloride bags because they were manufactured in a non-sterile facility and are not intended for human or animal use.
Product
Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0431-2015·2015-04-15
Navinta Recalls Fomepizole Injection Due to Sterility Assurance Concerns
Navinta LLC is recalling Fomepizole Injection due to FDA inspection findings of GMP violations that may impact sterility. The recall covers 14,628 units distributed nationwide.
Product
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0483-2015·2015-04-15
Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization
Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The recall covers vials distributed nationwide and internationally.
Product
KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0482-2015·2015-04-15
Hospira Recalls Ketorolac Tromethamine Injection Due to Crystallization
Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection because of crystallization. The affected vials were distributed nationwide and in Guam and Singapore.
Product
KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2015·2015-04-15
RemedyRepack Recalls Ketorolac Tromethamine Injection Vials Due to Crystallization
RemedyRepack Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The affected vials were distributed in Pennsylvania and Oklahoma.
Product
KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0436-2015·2015-04-15
Heritage Pharmaceuticals Recalls Gliptizide and Metformin Tablets Due to Impurity
Heritage Pharmaceuticals is recalling specific lots of Gliptizide and Metformin HCL tablets because they failed impurity specifications. The affected bottles were distributed nationwide.
Product
GLIPIZIDE AND METFORMIN HCL — GLIPIZIDE AND METFORMIN HCL (GLIPIZIDE AND METFORMIN HCL)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0435-2015·2015-04-15
Mylan Recalls Fexofenadine HCl Tablets Due to Impurity Failures
Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 60 mg tablets because they failed impurity specifications. The recall covers 13,856 bottles distributed nationwide.
Product
Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D00432-2015·2015-04-15
Qualitest Recalls Promethazine VC With Codeine Syrup Due to Impurity
Qualitest Pharmaceuticals is recalling Promethazine VC with Codeine Syrup because a stability lot failed impurity specifications.
Product
PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for…
Category
Drug
Distribution
Distributed nationwide

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14501–14525 of 18001