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

626–650 of 810

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-452-2015·2015-04-15
Recall of Compounded TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling five bags of compounded Total Parenteral Nutrition (TPN) because they failed sterility tests for microbial contamination.
Product
Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium Gluconate 8mEq, 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
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-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-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 lined
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-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-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-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-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-463-2015·2015-04-15
FDA Recalls Six Bags of Neonatal TPN Due to Sterility Failure
Central Admixture Pharmacy Services is recalling six bags of compounded neonatal TPN because sterility tests failed. The product was distributed nationwide.
Product
Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neonate 12.5g, Dextrose 10%, 500 ml, Additives: heparin PF 250 units, Calcium Gluconate 1250mg, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box
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-437-2015·2015-04-15
CAPS Recalls 20 Bags of TPN Neonatal Starter Bag for Sterility Failure
Central Admixture Pharmacy Services is recalling 20 bags of University of Alabama Birmingham TPN Neonatal Starter Bag due to out-of-specification sterility test results.
Product
University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, 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-0392-2015·2015-02-25
Hospira Recalls Lactated Ringer's Injection Due to Confirmed Mold Particulates
Hospira Inc. is recalling 142,644 bags of Lactated Ringer's and 5% Dextrose Injection USP due to confirmed mold particulates in the solution.
Product
LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0306-2015·2014-12-31
Glutathione Injection Recalled for Potential Non-Sterility
Pharmacy Creations is recalling 12 vials of Glutathione 100mg/mL Sterile Injection due to failing sterility test results.
Product
Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Category
Drug
Distribution
4 states
CriticalFDA (Drugs)·D-0305-2015·2014-12-31
Pharmacy Creations Recalls Ascorbic Acid Injection Due to Sterility Failure
Pharmacy Creations is recalling 67 vials of Ascorbic Acid 500 mg/mL Sterile Injection because contract testing indicated the product may not be sterile.
Product
Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Category
Drug
Distribution
4 states
CriticalFDA (Drugs)·D-0307-2015·2014-12-31
Pharmacy Creations Recalls Magnesium Chloride Injection Due to Sterility Concerns
Pharmacy Creations is recalling 52 vials of Magnesium Chloride 20% Injection because contract testing indicated the product may not be sterile.
Product
Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Category
Drug
Distribution
4 states
CriticalFDA (Drugs)·D-0308-2015·2014-12-31
Pharmacy Creations Recalls Non-Sterile Ophthalmic Solution
Pharmacy Creations is recalling 50 bottles of Tropi/Cyclo/Phenyl/Tobra/Flurb sterile ophthalmic solution due to failing sterility test results.
Product
Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Category
Drug
Distribution
4 states
CriticalFDA (Drugs)·D-0250-2015·2014-11-26
Abrams Royal Pharmacy Recalls Calcium Chloride Injection Due to Sterility Failures
Abrams Royal Pharmacy is recalling 1,100 vials of Calcium Chloride Preservative Free Sterile Injection because contract testing found sterility failures.
Product
Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
Category
Drug
Distribution
0 states
CriticalFDA (Drugs)·D-0252-2015·2014-11-26
Abrams Royal Pharmacy Recalls Trace Mineral-5 MDV Due to Non-Sterility
Abrams Royal Pharmacy is recalling Trace Mineral-5 MDV vials because a contract laboratory identified Staphylococcus warneri in the product, indicating non-sterility.
Product
Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0251-2015·2014-11-26
Abrams Royal Pharmacy Recalls Non-Sterile Lidocaine and Bupivacaine Syringes
Abrams Royal Pharmacy is recalling 50 syringes of a compounded lidocaine and bupivacaine mixture due to non-sterility. The products were distributed in Texas.
Product
Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0230-2015·2014-11-05
FDA Recalls Calcium Glucosate Injection Due to Microbial Contamination
Specialty Compounding, LLC is recalling Calcium Gluconate 2 gm in 100 mL Sodium Chloride 0.9% for Injection due to non-sterility and microbial contamination.
Product
CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0011-2015·2014-10-15
Unique Pharmaceutical Recalls N-Acetyl Cysteine Vials Due to Non-Sterility
Unique Pharmaceutical, Ltd is recalling one lot of N-Acetyl Cysteine 20% vials because testing revealed the presence of Herbaspirillum huttiense bacteria.
Product
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1610-2014·2014-10-08
Baxter Recalls Dianeal Low Calcium Peritoneal Dialysis Solution Bags
Baxter Healthcare is recalling 50,530 bags of Dianeal Low Calcium peritoneal dialysis solution due to the presence of particulate matter found during manufacturing.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide

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