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

2351–2375 of 17964

HighFDA (Drugs)·D-0987-2023·2023-08-09
NORepinephrine IV Bags Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling NORepinephrine 4 mg/250 mL IV bags due to lack of sterility assurance caused by insufficient validation of decontamination cycles. The affected lots were distributed nationwide.
Product
NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8097-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0979-2023·2023-08-09
Heparin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 5,834 bags of heparin 5000 units/500mL IV bags nationwide due to insufficient validation of sterilization processes, creating potential contamination risk.
Product
heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0988-2023·2023-08-09
Norepinephrine IV bags recalled for sterility validation deficiency
Central Admixture Pharmacy Services recalled 80 bags of norepinephrine IV solution due to lack of sterility assurance and insufficient validation data for decontamination cycles. Product was distributed nationwide.
Product
norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0989-2023·2023-08-09
FDA Recalls IV Potassium Phosphate Solution Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 7,469 bags of potassium phosphate IV solution nationwide because decontamination validation data is lacking, creating a sterility assurance gap.
Product
potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1055-2023·2023-08-09
Hydromorphone Injection Syringes Recalled for Sterility Validation Deficiency
Central Admixture Pharmacy Services is recalling 2,389 hydromorphone injection syringes distributed nationwide due to lack of validation data for sterilization procedures, which prevents assurance of product sterility.
Product
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1033-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services has recalled 80 bags of Cardioplegia Solution (NDC 72196-0210-1) distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1066-2023·2023-08-09
FDA Recalls PHENYLephrine Syringes Due to Sterility Validation Failure
FDA is recalling 81,073 PHENYLephrine syringes manufactured by Central Admixture Pharmacy Services. The manufacturer lacks validation data for its sterilization processes, so the syringes may not be sterile.
Product
PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1022-2023·2023-08-09
Cardioplegia Solution IV bags recalled for missing sterility validation
Central Admixture Pharmacy Services is recalling Cardioplegia Solution IV bags (Lot 36-252142) nationwide because decontamination validation data is lacking, preventing assurance of sterility.
Product
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1079-2023·2023-08-09
Fentanyl Injectable Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services is recalling approximately 6,770 fentanyl syringes distributed nationwide due to lack of validated sanitization data. The injectable medication may not have proper sterility assurance.
Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1062-2023·2023-08-09
Fentanyl Injectable Syringes Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 2,340 fentanyl syringes distributed nationwide due to lack of sterility assurance from unvalidated sanitization procedures.
Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1049-2023·2023-08-09
Compounded HYDROmorphone Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 2,228 HYDROmorphone injectables (0.1 mg/mL) due to lack of validation data for sanitization cycles affecting sterility assurance. Multiple lot numbers distributed nationwide are affected.
Product
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1025-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls Leesburg Cardioplegia Solution due to inadequate sterilization validation. The recall affects 36 bags distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1048-2023·2023-08-09
Vecuronium Injection Recalled Due to Lack of Sterility Validation
Vecuronium injection syringes were recalled nationwide due to lack of validation data for sanitization cycles, which raises sterility assurance concerns.
Product
vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1.
Category
Drug
Distribution
Distributed nationwide
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 (Drugs)·D-0965-2023·2023-08-09
PHENYLephrine Injectable Syringe Recall Due to Insufficient Sterility Assurance
Central Admixture Pharmacy Services recalls 499,304 PHENYLephrine syringes nationwide because validation data for sterility decontamination cycles was lacking. No illnesses have been reported.
Product
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1031-2023·2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (100 mEq K) due to inadequate validation of decontamination processes. The recall affects 284 units distributed nationwide. Affected facilities should discontinue use and contact the manufacturer.
Product
CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0107-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1011-2023·2023-08-09
Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 420 neonatal TPN starter bags due to lack of sterility assurance and validation data for decontamination cycles. The recalled lots were distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1030-2023·2023-08-09
Cardioplegia Solution 122 mEq K Recalled for Sterility Failure
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination. The product was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0209-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1075-2023·2023-08-09
FDA Recalls Midazolam Injectable for Unvalidated Sterilization Process
Central Admixture Pharmacy Services Inc is recalling 621 syringes of midazolam injection because the manufacturer lacked validation data to confirm the sterilization process was effective.
Product
midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1067-2023·2023-08-09
Fentanyl-bupivacaine injection syringes recalled due to sterility assurance issue
Central Admixture Pharmacy Services is recalling 1,486 syringes of fentanyl-bupivacaine injection nationwide due to lack of validated sanitization processes that may affect product sterility.
Product
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1005-2023·2023-08-09
Neonatal TPN IV Bags Recalled Over Sterility Assurance Failures
Central Admixture Pharmacy Services is recalling 304 neonatal TPN IV starter bags nationwide due to lack of sterility assurance and insufficient validation of decontamination processes. No illnesses have been reported.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1059-2023·2023-08-09
Fentanyl IV Bags Recalled for Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 19,014 bags of fentanyl IV injection nationwide due to lack of validated sterilization processes, which could affect product sterility.
Product
fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0977-2023·2023-08-09
Heparin IV bags recalled for lack of validated sterility assurance
Central Admixture Pharmacy Services is recalling 7,509 heparin IV bags nationwide because the company lacks validation data showing the sterilization process works. No illnesses have been reported.
Product
heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1006-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 108 Neonatal TPN Starter Bags (Lot 36-256338) due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1077-2023·2023-08-09
Phenylephrine Injectable Syringes Recalled Due to Sterility Validation Deficiency
Central Admixture Pharmacy Services recalled phenylephrine injectable syringes nationwide due to missing validation data for sanitization cycles. Approximately 10,494 syringes from multiple lots may not meet sterility assurance standards.
Product
PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
Category
Drug
Distribution
Distributed nationwide

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2351–2375 of 17964