Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

12326–12350 of 53080

HighFDA (Drugs)·D-1008-2023·2023-08-09
Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 124 neonatal TPN starter bags nationwide due to lack of sterility assurance from missing decontamination validation data.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0421-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1078-2023·2023-08-09
Phenylephrine Injection Syringes Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine injection due to lack of validation data for sterilization processes. The product was distributed nationwide.
Product
PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2329-2023·2023-08-09
Ultrasound Gel in Medline Procedural Kits Recalled Over Sterility Specification Concerns
Medline Industries recalled approximately 154,900 Custom Sterile and Non-Sterile Procedural Kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Model Number: DYNDA1219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2023·2023-08-09
Medline Procedural Kits Recalled Due to Sterility Specification Failure
Medline Industries recalls 15,945 Custom Sterile and Non-Sterile Procedural Kits due to potential failure of the Turkuaz ultrasound gel component to meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0950-2023·2023-08-09
Vancomycin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,824 bags of vancomycin IV medication nationwide due to inadequate validation of sterilization processes. The manufacturer cannot confirm proper sterility.
Product
vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2330-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel
Medline Industries is recalling 7,040 custom sterile procedural kits containing ultrasound gel because the gel component may not meet sterility specifications, creating a potential infection risk.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1336-2023·2023-08-09
Currants recalled for undeclared allergens: tree nuts, peanuts, wheat
Houston Pecan Company, Inc. is recalling 5-pound bags of currants because they may contain undeclared tree nuts, peanuts, and wheat due to allergen cross contamination. The recall covers all bags purchased before May 25, 2023 in Texas and through internet sales.
Product
Currants packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Food)·F-1343-2023·2023-08-09
Sweet & Salty Mix Recalled for Undeclared Tree Nuts, Peanuts, and Wheat
Houston Pecan Company is recalling Sweet & Salty Mix 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from cross-contamination. All bags purchased before May 25, 2023 are affected.
Product
Sweet & Salty Mix, Rst & Salted Peanuts, Rst & Salted Cashews, Raisins, Cranberries, Sunflower Seeds, Pumpkin Seeds, Sliced Almonds packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-1046-2023·2023-08-09
FDA Recalls Fentanyl Syringes for Sterility Assurance Failure
Central Admixture Pharmacy Services Inc. has recalled 100 fentanyl syringes (Lot 17-273267) because validation data for sanitization cycles is lacking, preventing assurance of sterility. The product was distributed nationwide.
Product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2325-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Failure
Medline is recalling 13,881 sterile procedural kits worldwide due to potential sterility failure in the ultrasound gel component. The affected kits are used in various medical insertion procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1363-2023·2023-08-09
Mondelez Recalls belVita Breakfast Sandwiches for Undeclared Peanut Allergen
Mondelez Global LLC is recalling belVita Breakfast Sandwiches (Dark Chocolate Creme variety) because they contain an undeclared peanut allergen due to cross contamination. Consumers with peanut allergies should not consume this product.
Product
belVita Breakfast Sandwich, Dark Chocolate Creme variety (192 - 2 lb 12 oz cartons per pallet)
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-1042-2023·2023-08-09
FDA Recalls Fentanyl Injections Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 1,197 syringes of fentanyl injectable solution due to lack of validation for sterilization cycles. The product was distributed nationwide.
Product
fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2001-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1334-2023·2023-08-09
Mango Slices Recalled for Undeclared Tree Nuts, Peanuts, and Wheat
Houston Pecan Company is recalling mango slices due to potential undeclared allergens: tree nuts, peanuts, and wheat. Affected products are 5-pound bags distributed in Texas and sold online.
Product
Mango Slices, Mango, Cane Sugar, Citric Acid, Calcium Chloride, Sulfur Dioxide packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-1018-2023·2023-08-09
FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (High K) IV bags due to lack of sterility assurance from insufficient validation of decontamination processes.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0212-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1036-2023·2023-08-09
Cardioplegia IV Solution Recalled for Sterilization Validation Deficiency
Central Admixture Pharmacy Services is recalling 88 bags of Cardioplegia Solution (Lot 36-255943) due to lack of assurance of sterility and insufficient validation of decontamination cycles. The product is used during cardiac surgery.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1362-2023·2023-08-09
BelVita Breakfast Sandwich recalled for undeclared peanut allergen
Mondelez is recalling belVita Breakfast Sandwich Dark Chocolate Creme and Cinnamon Brown Sugar varieties due to undeclared peanut allergen. The affected products were distributed to all 50 states.
Product
belVita Breakfast Sandwich, Dark Chocolate Creme variety (8 - 14.08 oz packages)
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2299-2023·2023-08-09
Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect
Medline Industries recalls 104,755 procedural kits due to potential sterility defect in ultrasound gel component. No illnesses or injuries have been reported.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1014-2023·2023-08-09
Neonatal TPN Starter Bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 80 Neonatal TPN Starter Bags due to lack of sterile assurance. Decontamination cycle validation data was not available, creating a potential contamination risk.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0423-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1056-2023·2023-08-09
Succinylcholine Injectable Syringes Recalled for Sterility Validation Deficiency
Central Admixture Pharmacy Services Inc recalls 12,239 succinylcholine injection syringes (200 mg/10 mL) distributed nationwide due to lack of validation data for sanitization cycles.
Product
succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1027-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling 132 bags of Cardioplegia Solution (Lot 36-254403) nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles used in the manufacturing process.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1338-2023·2023-08-09
Dark Chocolate Pecans Recalled for Potential Undeclared Tree Nuts and Peanuts
Houston Pecan Company is recalling dark chocolate pecans in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross-contamination. Consumers with allergies should not consume the product.
Product
Dark Chocolate Pecans packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-1028-2023·2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 196 bags of cardioplegia solution nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1040-2023·2023-08-09
Cardioplegia Solution IV Bags Recalled Due to Sterility Assurance
Central Admixture Pharmacy Services is recalling 72 bags of Cardioplegia Solution due to insufficient validation data for product sterilization processes.
Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2301-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Specification Failure
Medline is recalling 41,123 procedural kits containing ultrasound gel that may fail to meet sterility specifications. The kits were distributed to healthcare facilities worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0953-2023·2023-08-09
IV Medication Recall: dilTIAZem Bags Lack Sterility Assurance
Central Admixture Pharmacy Services is recalling 3,699 bags of dilTIAZem IV medication due to lack of assurance of sterility and missing validation data for decontamination cycles. The affected medication was distributed nationwide.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
Category
Drug
Distribution
Distributed nationwide