Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

4901–4925 of 7439

CriticalFDA (Food)·F-1895-2015·2015-04-15
Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria
The Santa Barbara Smokehouse is recalling specific batches of smoked salmon because samples tested positive for Listeria monocytogenes.
Product
Oakwood and Whiskey smoked salmon sliced sides under the following brands; Cambridge House SKU: 8 30859 01163 2, Coastal Harbor SKU: 8 30859 01369 8 All products are vacuum packed and are either fresh or frozen. Products are cold smoked.
Category
Food
Distribution
17 states
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 a
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-461-2015·2015-04-15
Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags
Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to sterility test failures. The product was distributed nationwide.
Product
Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acids, Neonate 5g, Dextrose 7.5%, 250 ml, Additives: heparin PF 125 unit(s)/ml, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corr
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-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-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 (Food)·F-1909-2015·2015-04-15
H-E-B Gumbo Recalled for Undeclared Peanuts in Texas
H-E-B Houston Culinary Center is recalling specific gumbo products sold in Texas due to undeclared peanuts. The recall is voluntary and classified as Class I by the FDA.
Product
H-E-B Single Serving Gumbo 8 oz.; H-E-B Houston Culinary Center Gumbo - Bulk 2/10 lb poly bags
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-1886-2015·2015-04-15
Seattle Pops Cinnamon Frozen Pops Recalled for Listeria Risk
Seattle Pops is recalling Cinnamon Frozen Pops because they contain an ice cream ingredient potentially contaminated with Listeria monocytogenes.
Product
Cinnamon Frozen Pops, 4.0 fl oz. frozen pop is individually packaged in a sealed plastic bag; 24 pops/case. Product is labeled in part, "***cream, milk, skim milk powder, non-gmo cane sugar, vanilla, cinnamon, less than 0.4% stabilizer (carob bean gum, guar gum, soy lecithin, c
Category
Food
Distribution
1 state
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 (Food)·F-1890-2015·2015-04-15
California Snack Foods Recalls Caramel Apples Due to Listeria Risk
California Snack Foods Inc. is recalling Karm'l Dapple caramel apples because they may be associated with a Listeria monocytogenes outbreak.
Product
Karm'l Dapple; Net Wt. 4 oz. (124g) Brown/Peanuts. Sold in Single size and 3 pack (12 oz. (340g) and Halloween Ingredients: Fresh Selected Apples, Sugar, Water Corn Syrup, Nonfat Dry Milk Solids, Cottonseed shortening and/or soybean oil, corn and soy cereal parts, flour, sal
Category
Food
Distribution
5 states
CriticalFDA (Food)·F-1879-2015·2015-04-15
Texamerican Cumin Recalled Due to Undeclared Peanut Allergen
Texamerican Food Blending is recalling 5 lb. bags of Cumin because two lots of ingredients were contaminated with peanut allergen, which is not listed on the label.
Product
Texamerican Cumin 5 lbs. Item Number: ARCH075-05
Category
Food
Distribution
4 states
CriticalFDA (Food)·F-1894-2015·2015-04-15
Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria
The Santa Barbara Smokehouse is recalling specific batches of smoked salmon because environmental and finished product samples tested positive for Listeria monocytogenes.
Product
Beechwood Smoked and Atlantic Salmon sliced sides, whole sides, and trimmings under the following brands; Coastal Harbor SKU: 8 30859 01183 0, Channel Island SKU: 8 30859 03093 0, Atlantic Smoked SKU: 8 30859 01253 0, Harbor Point SKU: 8 30859 01515 9, Local Abundance SKU: 8 3085
Category
Food
Distribution
17 states
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-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-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 (Food)·F-1899-2015·2015-04-15
Santa Barbara Smokehouse Recalls Smoked Salmon Pastrami Due to Listeria
The Santa Barbara Smokehouse is recalling smoked salmon pastrami because environmental and finished product samples tested positive for Listeria monocytogenes.
Product
Smoked salmon pastrami sliced side under the following brand; Cambridge House Royal SKU: 8 30859 01013 0 All products are vacuum packed and are either fresh or frozen. Products are cold smoked. A gold sticker is placed directly on the vacuum package of flavored smoked salmo
Category
Food
Distribution
17 states
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-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-454-2015·2015-04-15
CAPS Recalls Trophamine IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling Trophamine IV infusion bags because they failed sterility tests for microbial contamination.
Product
St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Additives: Calcium Gluconate 4.65mEq, 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,
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-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-466-2015·2015-04-15
Central Admixture Pharmacy Recalls Compounded IV Infusion Bags for Sterility Failure
Central Admixture Pharmacy Services is recalling specific compounded IV infusion bags due to out-of-specification sterility test results indicating microbial contamination.
Product
Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 5%, 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 contain
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-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 (Food)·F-1896-2015·2015-04-15
Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria Contamination
The Santa Barbara Smokehouse is recalling 1,018 lbs of Cambridge House Royal smoked salmon because samples tested positive for Listeria monocytogenes.
Product
Smoked salmon lemon dill sliced side under the following brand; Cambridge House Royal SKU: 8 30859 01018 5 All products are vacuum packed and are either fresh or frozen. Products are cold smoked. A gold sticker is placed directly on the vacuum package of flavored smoked sal
Category
Food
Distribution
17 states