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

1751–1775 of 3644

HighFDA (Drugs)·D-1125-2023·2023-09-06
FDA Recalls Phenylephrine IV Bags Due to Sterility Validation Concerns
Central Admixture Pharmacy Services is recalling 586 bags of phenylephrine IV solution due to lack of validation data for sterilization cycles. These bags may not meet sterility assurance requirements for intravenous use.
Product
PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1119-2023·2023-09-06
Neonatal TPN Starter Bags Recalled for Insufficient Sterilization Validation
Central Admixture Pharmacy Services is recalling 136 neonatal TPN starter bags due to lack of validated sterilization cycles. The recall affects bags distributed nationwide with lot numbers 36-262160 and 36-262146.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/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: 72196-0428-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1127-2023·2023-09-06
FDA Recalls Phenylephrine IV Bags Due to Unvalidated Sanitization
Central Admixture Pharmacy Services is recalling 292 bags of phenylephrine IV solution due to unvalidated sanitization cycles that cannot assure product sterility. No illnesses have been reported.
Product
PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1123-2023·2023-09-06
Cardioplegia Solution Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to lack of validation data for sanitization cycles, which cannot assure product sterility.
Product
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1129-2023·2023-09-06
FDA Recalls EPINEPHrine IV Bags for Unvalidated Sterilization Processes
Central Admixture Pharmacy Services is recalling 340 bags of epinephrine IV solution due to inadequate validation of sterilization procedures, creating a potential contamination risk.
Product
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1134-2023·2023-09-06
OxyTOCIN IV Bags Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 298 bags of oxyTOCIN 40 units IV bags nationwide due to lack of validation data for sanitization cycles, creating potential sterility concerns.
Product
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1135-2023·2023-09-06
FDA Recalls Heparin IV Bags Due to Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 577 bags of heparin IV solution (2500 units/500mL) nationwide due to lack of validation data for sanitization cycles, which could compromise sterility assurance.
Product
heparin added to 0.9% sodium chloride, 2500 units/500mL (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-1128-2023·2023-09-06
Phenylephrine IV Injection Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls phenylephrine IV bags nationwide because the manufacturer lacks validated sanitization data to ensure sterility. Healthcare providers should identify and quarantine affected inventory.
Product
PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1136-2023·2023-09-06
Vancomycin Injectable Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling vancomycin injections nationwide (477 bags, lots 36-262215 and 36-262216) due to lack of validation data for sanitization cycles, which prevents assurance of product sterility.
Product
vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1100-2023·2023-08-30
Sodium Fluoride Activator Concentrate Recalled for Manufacturing Practice Violations
Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate nationwide due to manufacturing practice deviations. The product was not manufactured under current good manufacturing practices (CGMP).
Product
activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1087-2023·2023-08-30
Rufinamide 200 mg Tablets Recalled for Manufacturing Process Deviation
Aurobindo Pharma USA Inc. is recalling Rufinamide 200 mg tablets (Lot RB2023001A) because a batch was released prior to manufacturing approval. The FDA classified this as a Class II recall.
Product
RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1102-2023·2023-08-30
Lugol's Strong Iodine Solution Recalled Due to Manufacturing Quality Deviations
Ecometics, Inc. is recalling Lugol's Strong Iodine Solution nationwide due to manufacturing quality deviations. Consumers with affected prescription vials should consult their healthcare provider.
Product
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1104-2023·2023-08-30
OTC Drug Products Recalled for Rodent Contamination and Storage Violations
Inmar Supply Chain Solutions is recalling all OTC drug products due to potential rodent exposure in its distribution center and temperature excursions during storage that may have compromised product integrity.
Product
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-1101-2023·2023-08-30
FDA Recalls AstrinGyn Surgical Hemostatic Due to Manufacturing Practice Deviations
Ecometics is recalling 92,967 vials of AstrinGyn (Ferric Subsulfate) Aqueous due to manufacturing practice violations. The product was not manufactured under current good manufacturing practices (CGMP).
Product
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1105-2023·2023-08-30
Compounded Semaglutide/Cyanocobalamin Vials Recalled for Sterility Concerns
Tailor Made Compounding is recalling 9 vials of Semaglutide/Cyanocobalamin 2mg/0.4mg/mL due to inability to assure sterility. The product was distributed nationwide.
Product
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1106-2023·2023-08-30
NAD+ Injectable Vials Recalled for Sterility Assurance Deficiency
NAD+ 200mg/ml vials from Tailor Made Compounding are recalled nationwide due to lack of assurance of sterility (Lot#07192307A2, BUD 11/18/2023). Consumers should discontinue use and consult their healthcare provider.
Product
NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1097-2023·2023-08-30
Yager's Liniment Recalled for Manufacturing Practice Violations
Ecometics recalls Yager's Liniment due to manufacturing practice violations affecting products nationwide.
Product
YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1084-2023·2023-08-23
Toothpaste Label Mix-Up: Wrong Tube Labels in Strawberry Cartons
Hello wild strawberry fluoride toothpaste cartons contain tubes incorrectly labeled as hello fresh watermelon fluoride free toothpaste. 182,046 units affected nationwide.
Product
hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-p
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1081-2023·2023-08-09
Prescription Birth Control Tablets Recalled for Failed Stability Testing
Lupin Pharmaceuticals is recalling TYDEMY birth control tablets due to failed stability testing. Consumers should contact their healthcare provider.
Product
TYDEMY — TYDEMY (DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM)
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-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-0947-2023·2023-08-09
Rocuronium Injection Syringes Recalled for Sterility Assurance Deficiency
FDA recalls 77,554 rocuronium syringes nationwide due to lack of sterility assurance and inadequate validation data for sterilization processes. The drug was repackaged by Central Admixture Pharmacy Services, Inc.
Product
rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0955-2023·2023-08-09
Vancomycin IV Bags Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 15,304 bags of vancomycin IV solution due to lack of validation data confirming proper sterilization of the product.
Product
vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
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-1009-2023·2023-08-09
Neonatal TPN starter bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 244 neonatal TPN IV bags due to lack of assurance that the sterility process was validated. The manufacturer lacked adequate validation data for their decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
Category
Drug
Distribution
Distributed nationwide

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1751–1775 of 3644