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 18005

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-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 (Drugs)·D-1063-2023·2023-08-09
Fentanyl Injectable Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 1,044 bags of fentanyl injectable solution due to lack of validated sanitization procedures that could compromise sterility assurance. The product affects healthcare facilities nationwide.
Product
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1053-2023·2023-08-09
FDA Recalls Fentanyl Syringes Due to Sterility Validation Concerns
Central Admixture Pharmacy Services is recalling 1,669 fentanyl syringes nationwide due to lack of validation data for sanitization cycles, preventing assurance of product sterility.
Product
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1074-2023·2023-08-09
Lidocaine Injectable Syringes Recalled for Sterilization Assurance Concerns
CAPS Inc. is recalling 9,517 lidocaine 2% injectable syringes distributed nationwide due to lack of sterilization validation data. No illnesses have been reported.
Product
lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0975-2023·2023-08-09
FDA Recalls oxyTOCIN IV Bags Over Sterility Assurance Failure
FDA recalled 751 bags of oxyTOCIN added to Lactated Ringer's IV solution nationwide due to lack of validation data for decontamination cycles, which left sterility assurance unconfirmed.
Product
oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1068-2023·2023-08-09
Morphine Injection Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling morphine injections nationwide due to inadequate validation of sterilization procedures, which poses a potential sterility risk.
Product
morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1043-2023·2023-08-09
Fentanyl injection syringes recalled for unvalidated sterilization process
Central Admixture Pharmacy Services is recalling 5,124 fentanyl syringes because the manufacturer lacks validation that its sterilization process is effective. The nationwide recall affects multiple lot numbers distributed through September 2023.
Product
fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1032-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of sterility assurance and missing validation data for manufacturing decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1
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-1051-2023·2023-08-09
Fentanyl Injectable Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling fentanyl injections because sterilization procedures were not properly validated, raising infection risks from potential contamination.
Product
fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1001-2023·2023-08-09
FDA Recalls Neonatal TPN Starter Bag for Lacking Sterility Assurance
Central Admixture Pharmacy Services recalls 68 neonatal TPN starter bags nationwide due to lack of validation data for decontamination cycles, posing a contamination risk.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% 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: 72196-0427-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0961-2023·2023-08-09
Phenylepherine IV bags recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling over 8,300 phenylepherine IV bags nationwide because sterilization procedures were not adequately validated. Sterility cannot be assured for the affected units.
Product
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1047-2023·2023-08-09
Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 1,216 fentanyl 2500 mcg/50 mL syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure sterility.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0969-2023·2023-08-09
Vancomycin IV bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 6,782 bags of vancomycin IV bags distributed nationwide due to lack of validation data for decontamination cycles, which compromises sterility assurance.
Product
vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1024-2023·2023-08-09
Cardioplegia solution IV bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 308 bags of cardioplegia solution nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0206-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0967-2023·2023-08-09
Vancomycin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 6,772 bags of vancomycin IV solution nationwide due to lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product
vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0958-2023·2023-08-09
Epinephrine IV solution bags recalled due to inadequate sterilization validation
Central Admixture Pharmacy Services is recalling 6,784 bags of Epinephrine IV solution nationwide because validation data for decontamination and sterilization processes is lacking, creating a potential contamination risk.
Product
EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
Category
Drug
Distribution
Distributed nationwide
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-0980-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Validation Concerns
Central Admixture Pharmacy Services recalled 52 neonatal TPN starter bags nationwide due to lack of validation data for sterilization processes, raising concerns about sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/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: 72196-0430-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1060-2023·2023-08-09
HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.
Product
HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0956-2023·2023-08-09
Cardioplegia Solution del Nido Formula Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 10,480 bags of Cardioplegia Solution del Nido Formula nationwide due to missing validation data for decontamination cycles, creating potential sterility assurance risks.
Product
Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1070-2023·2023-08-09
Fentanyl and Bupivacaine Injectable Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 1,114 bags of fentanyl and bupivacaine injectable due to lack of validation data for sterilization. The product was distributed nationwide.
Product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1044-2023·2023-08-09
HYDROmorphone Injectable Syringes Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services Inc is recalling HYDROmorphone injectable syringes because sterilization cycles were not validated. The recall affects 2,717 units distributed nationwide.
Product
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1069-2023·2023-08-09
Injectable Fentanyl-Bupivacaine Mixture Recalled for Sterility Validation Failure
Central Admixture Pharmacy Services recalls 295 bags of injectable fentanyl-bupivacaine solution nationwide because the sterilization process lacked proper validation documentation.
Product
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
Category
Drug
Distribution
Distributed nationwide

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2351–2375 of 18005