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.

13001–13025 of 53082

HighFDA (Drugs)·D-0685-2023·2023-05-31
Neonatal TPN Starter Bags Recalled for Sterility Assurance Issue
Central Admixture Pharmacy Services recalls 138 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned the products' sterility assurance. Affected lots expire between April and May 2023.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0407-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0707-2023·2023-05-31
Injectable Oxytocin Lactated Ringer's Solution Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 21,871 bags of injectable oxytocin mixed with Lactated Ringer's solution nationwide due to sterility assurance failures identified during an FDA inspection.
Product
oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6039-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0914-2023·2023-05-31
Country Cookie Chocolate Brownies Recalled for Undeclared Milk Allergen
Country Cookie Chocolate Brownies sold in Missouri and Kansas are being recalled because they contain milk but the allergen is not declared on the label.
Product
Country Cookie Chocolate Brownie, plastic clamshell
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0716-2023·2023-05-31
IV Potassium Phosphate Solution Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalls 9,432 bags of potassium phosphate injectable solution nationwide following FDA inspection findings that questioned the sterility of these pharmaceutical products.
Product
potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6060-1.
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·23V366000·2023-05-31
Marion Body Works Recalls 2022-2023 Spartan Fire Trucks for Transmission Defect
Marion Body Works is recalling 2022 Spartan Fire Gladiator and 2023 Spartan Fire MetroStar emergency vehicles because the transmission control module may fail to engage 4th gear lockup, preventing the water pump from starting.
Product
MARION BODY WORKS — MARION BODY WORKS SPARTAN FIRE METROSTAR, SPARTAN FIRE GLADIATOR
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0951-2023·2023-05-31
TruBoost Drink Ruby Rev recalled for unapproved dietary ingredients
TruVision Health LLC is recalling TruBoost Drink - Ruby Rev because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.
Product
TruBoost Drink - Ruby Rev
Category
Food
Distribution
50 states
HighFDA (Drugs)·D-0719-2023·2023-05-31
Vancomycin Dextrose Injectable Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 13,772 bags of vancomycin-dextrose injectable distributed nationwide after an FDA inspection questioned its sterility assurance. No illnesses have been reported.
Product
vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0711-2023·2023-05-31
Oxytocin Injectable Drug Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 1,332 bags of oxytocin injectable solution due to FDA concerns about sterility assurance. The company could not confirm the product met sterility standards after an FDA inspection.
Product
oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1617-2023·2023-05-31
Omnicell IVX Station medical device recalled for dose accuracy failures
OmniCell recalls six Omnicell IVX Station devices used for automated pharmaceutical preparation. The devices may not account for scale inaccuracy, potentially allowing incorrect doses to pass quality checks.
Product
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Category
Medical Device
Distribution
2 states
HighFDA (Drugs)·D-0695-2023·2023-05-31
Neonatal TPN Starter Bags Recalled for Unassured Sterility
Central Admixture Pharmacy Services is recalling 135 bags of neonatal TPN starter bags distributed nationwide because the FDA found inadequate assurance of sterility during inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low 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 71285-0425-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0697-2023·2023-05-31
Neonatal TPN Bags Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services recalled 485 bags of Neonatal TPN Starter Bag nationwide due to FDA concerns about manufacturing sterility assurance. No illnesses have been reported.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low 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 71285-0428-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1626-2023·2023-05-31
Diagnostic Cartridge Assay May Fail to Detect Chlamydia Trachomatis Correctly
Binx Health is recalling a single lot of its CT/NG diagnostic cartridges distributed in Pennsylvania. The cartridges may not accurately detect Chlamydia trachomatis, potentially producing false negative or false positive results.
Product
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-0938-2023·2023-05-31
Julie's Real JR Bar Granola Bars Recalled for Possible Metal Contamination
Julie's Real JR Bar Cinnamon Vanilla Bean Grain-Free Granola Bars are being recalled due to possible presence of metal. The recall affects approximately 22,290 boxes distributed nationwide.
Product
Julie's Real JR Bar Cinnamon Vanilla Bean Grain-Free Granola Bar, Net Wt 1.4 oz (40g), UPC 857628006699, packaged and sold in a 6 Pack Box to consumers, sold as a Master Case of 6, 6 Pack Boxes to retailer and distributor
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1613-2023·2023-05-31
Olympus Single Use Distal Cover for Endoscope Recalled Due to Detachment Risk
Olympus is recalling about 309,278 single-use endoscope covers that may detach during use, risking aspiration, inhalation, obstruction, or burns.
Product
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0670-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution for lack of assurance of sterility. FDA inspection questioned the sterility of this injectable product; 241 bags were distributed nationwide.
Product
Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0204-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0681-2023·2023-05-31
Cardiac Perfusion Solution Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Modified del Nido Microplegia syringes after an FDA inspection raised concerns about their sterility. Approximately 690 syringes distributed nationwide may be affected.
Product
Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0909-2023·2023-05-31
Country Cookie Molasses Cookies Recalled for Undeclared Milk Allergen
Country Cookie LLC is recalling molasses cookies due to undeclared milk allergen on the label. Consumers with milk allergies who consume this product face serious allergic reactions.
Product
Country Cookie Molasses cookie, plastic wrapped
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0754-2023·2023-05-31
FDA Recalls HyperLyte CR Injection for Lack of Sterility Assurance
The FDA recalled HyperLyte CR Injection because the manufacturer could not assure the product met sterility requirements. The recall affects 554 bags distributed nationwide.
Product
HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0908-2023·2023-05-31
Country Cookie M&M Cookies Recalled for Undeclared Milk Allergen
Country Cookie LLC is recalling M&M cookies and mini cups distributed in Missouri and Kansas because the label does not declare milk as an allergen. Consumers allergic to milk should discard the recalled products.
Product
Country Cookie M&M cookie, plastic wrapped; Country Cookie Mini Cups of Cookies M&M Cookie
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0731-2023·2023-05-31
Heparin Injection Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling heparin injectable solutions nationwide due to sterility concerns identified during an FDA inspection. Over 11,000 bags of the product are affected.
Product
heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0708-2023·2023-05-31
FDA Recalls Oxytocin Injection Bags Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,865 bags of oxytocin injection across the USA due to lack of sterility assurance identified during an FDA inspection. Sterile injectables must meet strict standards to prevent infection risk.
Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0666-2023·2023-05-31
Cardioplegia Solution Recalled Nationwide for Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls 613 bags of cardioplegia solution nationwide due to FDA inspection concerns about sterility assurance.
Product
Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0686-2023·2023-05-31
Neonatal TPN Starter Bags Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 167 bags of neonatal TPN Starter Bag due to FDA concerns about product sterility identified during inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0408-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0949-2023·2023-05-31
TruBoost 7 Day Experience Kit dietary supplement recalled for prohibited ingredients
TruVision Health LLC recalls TruBoost 7 Day Experience Kit due to the presence of DMHA and/or hordenine, which the FDA determined are not acceptable dietary ingredients.
Product
TruBoost 7 Day Experience Kit
Category
Food
Distribution
50 states
HighFDA (Drugs)·D-0674-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
Category
Drug
Distribution
Distributed nationwide