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.

14751–14775 of 53092

HighFDA (Drugs)·D-0102-2023·2023-01-18
Mitomycin Injection Solution Recalled Due to Lack of Sterility Assurance
Mitomycin Injection Solution manufactured by Northern VA Compounders PLLC is being recalled because sterility cannot be assured. Patients receiving this product should contact their healthcare provider.
Product
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0251-2023·2023-01-18
Sanders Milk Chocolate Sea Salt Pecan Cluster Recalled for Brush Bristles
Sanders Candy LLC recalls Sanders Milk Chocolate Sea Salt Pecan Cluster due to foreign material—pieces of cleaning brush bristles—found in the product. The recall affects nearly 1 million units distributed nationwide and in Canada.
Product
Sanders Milk Chocolate Sea Salt Pecan Cluster: 0-35900-25550-2 .5OZ Individual Wrapped 0-35900-27486-2 25OZ Tub 0-35900-30971-7 18OZ Tub 0-35900-30170-4 7OZ Pouch
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0253-2023·2023-01-18
Sanders Dark Chocolate Maple Sea Salt Caramel Recalled for Foreign Material
Sanders Candy LLC is recalling Sanders Dark Chocolate Maple Sea Salt Caramel due to brush bristles found in the product. Consumers should not consume affected units.
Product
Sanders Dark Chocolate Maple Sea Salt Caramel: No UPC 6oz. foil bag
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0098-2023·2023-01-18
Rifampin Capsules Recalled Due to Failed Quality Specifications
RemedyRepack Inc. is recalling Rifampin Capsules, 300 mg, due to failed impurities and degradation specifications. The affected product was distributed to a single pharmacy account in Pennsylvania.
Product
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0126-2023·2023-01-18
TriMix Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders is recalling TriMix Injection due to inability to assure the product meets sterility standards required for injectable medications. The recall affects 2 vials distributed nationwide.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0933-2023·2023-01-18
Cystoscopy kits recalled for potential sterility breach from packaging defects
Henry Shein CYSTO SET UP PACK units are being recalled due to potential pinhole leaks in the outer bag that could compromise the sterility of the kit.
Product
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0921-2023·2023-01-18
Adult Craniotome Ball Bearing Separation Risk During Neurosurgery
The Anspach Adult Craniotome Large attachment ball bearings may separate during surgical removal or intra-operatively, potentially causing serious patient injury.
Product
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0942-2023·2023-01-18
Stradis Healthcare Neonatal PICC Trays recalled for potential sterility breach
Stradis Healthcare is recalling 2,500 units of Neonatal PICC Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The affected trays were distributed nationwide.
Product
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0939-2023·2023-01-18
HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks
Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.
Product
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0121-2023·2023-01-18
TriMix Injection Recalled Nationwide for Lack of Sterility Assurance
Northern VA Compounders recalls TriMix Injectable due to lack of sterility assurance in 8 vials distributed nationwide. Patients should consult their healthcare provider about affected doses.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0252-2023·2023-01-18
Sanders Dark Chocolate Peppermint Recalled for Cleaning Brush Bristles
Sanders Dark Chocolate Peppermint Sea Salt Caramel is recalled nationwide and in Canada due to contamination with cleaning brush bristles. Products with Best By dates from October and December 2023 are affected.
Product
Sanders Dark Chocolate Peppermint Sea Salt Caramel: UPC 0-35900-30857-4 18OZ Tub UPC 0-35900-30919-9 32OZ Tub
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0100-2023·2023-01-18
Prescription Rifampin Capsules Recalled for Failed Impurity Specifications
Lupin Pharmaceuticals is recalling Rifampin Capsules (300 mg) nationwide due to failed impurity and degradation specifications found during stability testing. Lot A200171 (exp. 12/2023) is affected, with over 16,000 bottles distributed.
Product
RIFAMPIN — RIFAMPIN (RIFAMPIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0257-2023·2023-01-18
Take & Bake Sourdough Biscuits recalled for unlabeled milk and wheat allergens
Hippos and Hashbrowns is recalling Take & Bake Sourdough Biscuits (UPC 44216-26512) because the label does not declare milk and wheat allergens. Consumers with these allergies should not consume this product.
Product
Take & Bake Sourdough Biscuits UPC 44216-26512 packaged in metal tin with clear plastic nonflexible lid
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0099-2023·2023-01-18
Rocuronium Bromide Injection Recalled for Lack of Sterility Assurance
Rocuronium Bromide Injection syringes from Nephron Sterile Compounding Center are being recalled because the manufacturer cannot verify the product is sterile. The recall affects approximately 38,830 pre-filled syringes distributed nationwide.
Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0256-2023·2023-01-18
Take & Bake Everything Biscuits recalled for undeclared milk and wheat allergens
Hippos and Hashbrowns is recalling Take & Bake Everything Biscuits due to missing allergen labeling for milk and wheat. The product label does not include the common names for these allergens.
Product
Take & Bake Everything Biscuits UPC 44216-26532 packaged in metal tin with clear plastic nonflexible lid
Category
Food
Distribution
1 state
HighFDA (Food)·F-0247-2023·2023-01-18
Taro Flavor Powder Recalled for Undeclared Milk and Color Additive Mislabeling
RED SUN TARO FLAVOR POWDER is recalled due to undeclared milk (sodium caseinate) and incorrect color additive labeling. The product was distributed in Iowa and may pose a risk to consumers with milk allergies.
Product
RED SUN TARO FLAVOR POWDER NET WT 1000g (2.2 LBS) packaged in PEP and aluminum foil bag
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0952-2023·2023-01-18
Medical device software bug may cause patient sample order mismatches in rare cases
A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.
Product
cobas infinity central lab, Material Number 07154003001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0944-2023·2023-01-18
Stradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise
Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.
Product
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2023·2023-01-18
Source Administration Set medical device recalled for contamination
The FDA has recalled 2,840 units of the Source Administration Set, a medical device used for PET imaging, due to contamination with black specks on needles.
Product
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0120-2023·2023-01-18
Compounded QuadMix injectable recalled for sterility assurance concerns
Northern VA Compounders PLLC recalled QuadMix Injectable nationwide due to lack of assurance of sterility. Patients who received this compounded medication should contact their healthcare provider immediately.
Product
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0114-2023·2023-01-18
TriMix Injection Recalled Due to Sterility Assurance Failure
Northern VA Compounders is recalling TriMix Injection due to lack of assurance of sterility. The affected lot (11142022@11, exp. 12/29/2022) was distributed nationwide. No illnesses have been reported.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2023·2023-01-18
Sterile EVA Medical Bags Recalled Due to Pinhole Leak Risk
Stradis Healthcare recalls HCT 50mL sterile EVA bags due to potential pinhole leaks near the seal that could compromise sterility. Approximately 2,779 units were distributed nationwide.
Product
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2023·2023-01-18
Craniotome Attachment Ball Bearings May Detach During Surgery
The Anspach 6.5 cm Adult Rotating Craniotome Attachment may have ball bearings that detach during surgical use or removal. The manufacturer recommends following inspection intervals to prevent serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0940-2023·2023-01-18
Central Line Insertion Trays Recalled for Potential Sterility Breaches
Stradis Healthcare is recalling HCT Central Line Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. Approximately 1,176 units were distributed nationwide.
Product
HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2023·2023-01-18
Tacy Medical Syringe Convenience Packs Recalled Due to Potential Sterility Loss
Tacy Medical syringe convenience packs may have pinhole leaks near the seal that compromise sterility. Affected lots 222270319 and 220834335 were distributed across 10 U.S. states.
Product
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide