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 deaths or serious injuries are reported, 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

6551–6575 of 8593

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 containe
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-451-2015·2015-04-15
Central Admixture Pharmacy Services Recalls TPN Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling 5 bags of Total Parenteral Nutrition (TPN) compounded for Walter Reed National Military Medical Center because sterility tests failed.
Product
Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, Dextrose 20g, compound vol: 200 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-458-2015·2015-04-15
CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling 4 bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.
Product
Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, 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-467-2015·2015-04-15
CAPS Recalls Neonatal TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling five bags of neonatal TPN due to out-of-specification sterility test results.
Product
Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, Dextrose 10%, 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-443-2015·2015-04-15
FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.
Product
Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a poly
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-441-2015·2015-04-15
CAPS Recalls Neonate Starter IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of Neonate Starter IV infusion bags because they failed sterility tests for microbial contamination.
Product
The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, 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-444-2015·2015-04-15
FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.
Product
Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a p
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-439-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Compounded IV Infusion Bags
Central Admixture Pharmacy Services is recalling 8 bags of compounded IV infusion bags due to out-of-specification sterility test results.
Product
Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, 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-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-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-456-2015·2015-04-15
CAPS Recalls Trophamine UAC Solution Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling Trophamine UAC Solution because it failed sterility tests for microbial contamination.
Product
Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g, compound vol: 100 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-448-2015·2015-04-15
Central Admixture Pharmacy Services Recalls NICU TPN Starter Due to Sterility Failure
Central Admixture Pharmacy Services is recalling a specific lot of NICU TPN Starter IV bags because sterility tests showed microbial contamination.
Product
Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a pol
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-469-2015·2015-04-15
FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of neonatal TPN bags due to out-of-specification sterility test results.
Product
Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , Dextrose 10%, 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-468-2015·2015-04-15
FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of a compounded neonatal TPN product because sterility testing failed. The product was distributed nationwide.
Product
Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contai
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 contain
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-464-2015·2015-04-15
CAPS Recalls Lankenau Hospital TPN Neonatal Starter Bags for Sterility Failure
Central Admixture Pharmacy Services is recalling six Lankenau Hospital TPN Neonatal Starter Bags due to out-of-specification sterility test results.
Product
Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5 units, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined wit
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-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-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 corru
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 inser
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
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-0429-2015·2015-04-08
Baxter Recalls Sodium Chloride Injection Due to Sterility Assurance Issues
Baxter Healthcare is recalling 196,128 containers of 0.9% Sodium Chloride Injection due to lack of sterility assurance and leak complaints.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0428-2015·2015-04-08
Baxter Recalls Clinimix E Due to Sterility Assurance Concerns
Baxter Healthcare is recalling 7,444 containers of Clinimix E 5/20 due to a lack of assurance of sterility and increased leak complaints.
Product
CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

6551–6575 of 8593