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.

13026–13050 of 53082

HighFDA (Drugs)·D-0679-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Cardioplegia Solution (325 bags nationwide) after FDA inspection identified loss of sterility assurance. Product is used in cardiac surgery and requires prescription.
Product
Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0895-2023·2023-05-31
The Traveler's Best sandwiches recalled for undeclared sesame allergen
GH Foods LLC is recalling The Traveler's Best Ham & Swiss on Pretzel Roll sandwiches due to undeclared sesame seeds. Sesame is a major allergen; consumers with sesame allergies face serious health risks.
Product
The Traveler's Best Ham & Swiss on Pretzel Roll Smoked Ham and Swiss Cheese With Lettuce and Dijon Mustard on a Pretzel Roll Ingredients: Pretzel Bun (Enriched Wheat Flour (Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid), Water…
Category
Food
Distribution
4 states
HighFDA (Food)·F-0950-2023·2023-05-31
TruBoost Drink Citrine Spark Recalled for Prohibited Dietary Ingredients
TruVision Health LLC is recalling TruBoost Drink - Citrine Spark because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients. Consumers should not consume the product.
Product
TruBoost Drink - Citrine Spark
Category
Food
Distribution
50 states
HighFDA (Drugs)·D-0673-2023·2023-05-31
Cardioplegia Solution Recall Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of assurance of sterility. An FDA inspection raised concerns about whether the 329 bags were properly sterilized.
Product
Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0689-2023·2023-05-31
Neonatal TPN Starter Bag Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalled 92 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned product sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/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 71285-0418-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0752-2023·2023-05-31
Potassium Acetate Injection Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Potassium Acetate Injection after an FDA inspection raised concerns about sterility assurance. The recall affects 3,326 bags nationwide.
Product
Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0936-2023·2023-05-31
Simple Truth Plant Based Ranch Dressing Mislabeled as Caesar Dressing
Litehouse Inc. is recalling Simple Truth Plant Based Ranch Dressing 12 oz bottles (UPC 01110609779) because bottles labeled as ranch dressing contain Caesar dressing instead. Affected product has lot code 1713802052623 and was distributed in Indiana.
Product
Simple Truth Plant Based Ranch Dressing 12floz bottle UPC 01110609779. 6 retail bottle per wholesale case.
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0654-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags distributed nationwide.
Product
Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0917-2023·2023-05-31
Country Cookie Pumpkin Bars Recalled for Undeclared Milk Allergen
Country Cookie Pumpkin Bars are being recalled because the product label fails to declare milk as an ingredient, posing a risk to consumers with milk allergies. Products with 'Baked On' dates through April 17, 2023, distributed in Missouri and Kansas are affected.
Product
Country Cookie Pumpkin Bar, plastic clamshell
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0758-2023·2023-05-31
Glimepiride Tablets recalled due to manufacturing practice deviations
Amerisource Health Services is recalling 105,361 bottles of Glimepiride Tablets nationwide following FDA discovery of manufacturing practice deviations. No illnesses have been reported.
Product
Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0714-2023·2023-05-31
FDA Recalls Norepinephrine Injection Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 2,041 bags of norepinephrine injection nationwide due to FDA concerns about product sterility. Healthcare providers should immediately stop using affected lots.
Product
norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6056-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0656-2023·2023-05-31
FDA Recalls Microplegia Solution for Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls Microplegia Solution due to sterility assurance concerns identified during an FDA inspection. Affected product should not be used.
Product
Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0690-2023·2023-05-31
Neonatal TPN Starter Bags Recalled Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 418 bags of neonatal TPN starter bags nationwide due to loss of sterility assurance following FDA inspection. The prescription product contains amino acids, dextrose, calcium, and heparin.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% 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 71285-0419-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0918-2023·2023-05-31
Brooklyn Delhi Ghost Pepper Hot Sauce Recalled Due to Pressurization Risk
Brooklyn Delhi Ghost Pepper Hot Sauce may become pressurized during fermentation, posing a risk of eye, face, and hand injuries when opening the bottle. Consumers should stop using the product and contact the manufacturer.
Product
Brooklyn Delhi Ghost Pepper Hot Sauce, 5 oz., glass bottle
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0650-2023·2023-05-31
Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 255 bags of Cardioplegia Solution after FDA inspection questioned its sterility assurance. The product was distributed nationwide.
Product
Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0728-2023·2023-05-31
Potassium Phosphate Drug Product Recalled for Sterility Assurance Defect
Central Admixture Pharmacy Services recalled 2,146 bags of potassium phosphate with sodium chloride solution nationwide because FDA inspection raised concerns about whether the sterile products met required sterility standards.
Product
potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7016-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1628-2023·2023-05-31
VITROS Chemistry HbA1c Reagent Kit recalled due to inaccurate test results
Ortho-Clinical Diagnostics is recalling VITROS Chemistry HbA1c Reagent Kits due to potential for false-positive and false-negative results, which may lead to misdiagnosis.
Product
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0748-2023·2023-05-31
Vasopressin Injectable Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling vasopressin 40 units injectable because FDA inspection raised concerns about sterility assurance.
Product
vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0723-2023·2023-05-31
Drug Recall: Vancomycin Injectable Lacks Sterility Assurance
Central Admixture Pharmacy Services recalls 7,632 bags of vancomycin injectable (NDC 71285-6078-1) nationwide due to FDA-identified sterility assurance deficiency.
Product
vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0738-2023·2023-05-31
FDA Recalls Diphenhydramine Injectable for Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling 3,999 units of diphenhydramine injectable due to sterility assurance concerns identified during an FDA inspection. No illnesses have been reported.
Product
diphenhydrAMINE 50 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 71285-7090-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0896-2023·2023-05-31
Turkey and Havarti Sandwich Recalled for Undeclared Sesame Allergen
GH Foods LLC recalls Turkey and Havarti Sandwiches for containing sesame seeds not declared on the label. Sesame is a common allergen, and individuals with sesame allergies should not consume this product.
Product
Turkey and Havarti Sandwich NET WT. 8.55oz (242g) Perishable, Keep Refrigerated Contains Milk, Soy, Wheat. May contain egg. Distributed By: Renaissance Food Group, LLC 1730 Eastridge Ave. Riverside, CA 92507 www.rfgfoods.com UPC 26766 15584
Category
Food
Distribution
4 states
HighFDA (Food)·F-0948-2023·2023-05-31
Truvy Boost Dietary Supplement Kit Recalled for Unapproved Ingredients
TruVision Health LLC is recalling Truvy Boost 30-Day Experience Kit (Lot 13993) because it contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.
Product
Truvy Boost 30-Day Experience Kit
Category
Drug
Distribution
50 states
HighFDA (Drugs)·D-0667-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 476 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterile assurance.
Product
Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0706-2023·2023-05-31
Injectable oxyTOCIN and Lactated Ringer's Recalled Over Sterility Concerns
Central Admixture Pharmacy Services is recalling oxyTOCIN with Lactated Ringer's injection (14,362 bags) nationwide due to FDA inspection findings that questioned sterility assurance.
Product
oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6038-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1614-2023·2023-05-31
Cranial Hand Drill recalled due to rust on chuck components
Integra LifeSciences Corp. is recalling 337 units of the Codman Cranial Hand Drill due to rust contamination on the drill chuck. The rust may cause inflammation, infection, and complications requiring revision surgery.
Product
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607
Category
Medical Device
Distribution
1 state