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 the agency’s own highest classification or reported deaths or serious injuries, 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

23326–23350 of 114484

HighFDA (Drugs)·D-0655-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of assured sterility following an FDA inspection. The product poses a potential infection risk to surgical patients.
Product
Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0660-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 544 bags of Cardioplegia Solution distributed nationwide due to lack of sterility assurance identified during FDA inspection. No illnesses have been reported.
Product
Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0102-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0688-2023·2023-05-31
Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags after FDA inspection questioned whether these injectable products maintain required sterility standards.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0416-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0735-2023·2023-05-31
FDA Recalls Phenylephrine Injectable Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 1,735 bags of phenylephrine injectable nationwide after FDA inspection raised concerns about product sterility assurance. No illnesses have been reported.
Product
phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7039-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0937-2023·2023-05-31
Great Value Potato Chips Recalled for Undeclared Milk Protein
Great Value Kettle Cooked Lightly Salted Potato Chips from an Ohio distribution center were packaged with incorrect labeling that fails to declare milk protein, posing a risk to consumers with milk allergies.
Product
Great Value Kettle Cooked Lightly Salted Potato Chips packaged in 8oz individual plastic bags - 8 bags per case
Category
Food
Distribution
1 state
HighFDA (Food)·F-0946-2023·2023-05-31
Truvy 30-Day Experience Kit Recalled for Unacceptable Dietary Ingredients
TruVision Health LLC is recalling Truvy 30-Day Experience Kit because it contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.
Product
Truvy 30-Day Experience Kit
Category
Food
Distribution
50 states
HighFDA (Devices)·Z-1623-2023·2023-05-31
Philips Incisive CT System Recalled for Potential Image Orientation Error
Philips recalls the Incisive CT whole-body X-Ray imaging system in 22 units due to potential incorrect image orientation that could result in flipped or reversed images, leading to misdiagnosis, incorrect treatment, or unnecessary radiation exposure.
Product
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Category
Medical Device
Distribution
4 states
HighFDA (Drugs)·D-0649-2023·2023-05-31
Cardioplegia Solution recalled due to lack of sterility assurance
Central Admixture Pharmacy Services is recalling its Cardioplegia Solution due to lack of assurance of sterility. An FDA inspection determined that the sterility of these products intended for cardiac surgery could not be assured.
Product
Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0721-2023·2023-05-31
Vancomycin and Dextrose Injection Sterility Recall by Central Admixture
Central Admixture Pharmacy Services recalls 10,282 bags of vancomycin in dextrose 5% nationwide after FDA inspection raised sterility assurance concerns for this injectable pharmaceutical product.
Product
vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6075-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0902-2023·2023-05-31
Oatmeal Raisin Cookies Recalled for Undeclared Milk Allergen
Country Cookie LLC is recalling Oatmeal Raisin Cookies because the label does not declare milk allergen. The recall affects cookies distributed to retailers in Missouri and Kansas.
Product
Country Cookie Oatmeal Raisin Cookie, plastic wrapped
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0665-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services, Inc. is recalling 48 bags of Cardioplegia Solution after an FDA inspection found the manufacturer could not assure the product's sterility. The product was distributed nationwide.
Product
Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0107-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0753-2023·2023-05-31
Lidocaine Injectable Solution Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Lidocaine 2% HCl Injectable Solution nationwide due to lack of sterility assurance following an FDA inspection. The recall affects 1,516 bags distributed across the United States.
Product
Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0904-2023·2023-05-31
Country Cookie Sugar Cookies Recalled for Undeclared Milk Allergen
Country Cookie LLC is recalling Country Cookie Sugar Cookies because the allergen statement does not declare milk, a common allergen. Affected products were distributed to retailers in Missouri and Kansas.
Product
Country Cookie Sugar Cookie, plastic wrapped
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0715-2023·2023-05-31
Phenylephrine Injectable Solution Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 6,407 bags of phenylephrine injectable solution nationwide because FDA inspection questioned the sterility assurance of the product.
Product
PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0734-2023·2023-05-31
NORepinephrine Injectable Recalled Nationwide for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 6,341 bags of NORepinephrine nationwide due to FDA concerns about sterility assurance. An FDA inspection found the manufacturer could not adequately ensure the product's sterility.
Product
NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7036-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0942-2023·2023-05-31
reFORM Dietary Supplement Recalled for Containing Unapproved Ingredients
TruVision Health LLC is recalling reFORM dietary supplement because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.
Product
reFORM
Category
Food
Distribution
50 states
HighFDA (Drugs)·D-0732-2023·2023-05-31
FDA Recalls Heparin Injectable Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 5,207 bags of heparin injectable nationwide due to an FDA-identified sterility assurance failure. The company cannot guarantee the sterility of affected lot numbers.
Product
heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0910-2023·2023-05-31
Country Cookie No Bake cookies recalled for undeclared milk allergen
Country Cookie LLC is recalling Country Cookie No Bake cookies and Country Cookie Cup of Mini Cookies No Bake sold in MO and KS because the allergen statement fails to declare milk.
Product
Country Cookie No Bake cookie, plastic wrapped; Country Cookie Cup of Mini Cookies No Bake
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0765-2023·2023-05-31
Pain Reliever Caplets Recalled Due to Out-of-Specification Impurity
Aurobindo Pharma is recalling 87,360 bottles of Pain Reliever Acetaminophen caplets (500 mg) distributed nationwide through Walgreens due to failed impurity specifications discovered through customer complaints about discoloration.
Product
PAIN RELIEVER — PAIN RELIEVER (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0737-2023·2023-05-31
Diphenhydramine 25 mg intravenous bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services recalls 5,627 bags of diphenhydramine 25 mg intravenous solution nationwide. An FDA inspection called into question the sterility of the products intended to be sterile.
Product
diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7089-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0653-2023·2023-05-31
FDA Recalls Cardioplegia Solution Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution, Reperfusate 4:1 due to lack of sterility assurance identified during an FDA inspection. The recall affects 338 bags distributed nationwide.
Product
Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0008-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0669-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution (182 bags, nationwide distribution) due to lack of sterility assurance identified during FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0692-2023·2023-05-31
Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 427 bags of Neonatal TPN Starter Bag due to FDA concerns about sterility assurance. An FDA inspection questioned whether the product met required sterility standards.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0421-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0916-2023·2023-05-31
Country Cookie Carrot Cake Recalled for Undeclared Milk Allergen
Country Cookie LLC recalled Country Cookie Carrot Cake products because the packaging fails to declare milk as an allergen. The recall affects clamshell packages distributed to retailers in Missouri and Kansas.
Product
Country Cookie Carrot Cake, plastic clamshell
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0652-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Defect
Central Admixture Pharmacy Services, Inc. is recalling 140 bags of Cardioplegia Solution due to lack of assurance of sterility following an FDA inspection. The product was distributed nationwide.
Product
Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0007-1.
Category
Drug
Distribution
Distributed nationwide

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23326–23350 of 114484