21 loaded recalls on this report date. 4 Class I. 21 ongoing.
Drugs
Not Yet Classified
Ongoing
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
Firm: OurPharma LLC
Reason: Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
openFDA source record
Drugs
Class III
Ongoing
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
Firm: Ajanta Pharma USA Inc
Reason: Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
openFDA source record
Drugs
Class III
Ongoing
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewo...
Firm: ImprimisRx NJ LLC
Reason: Subpotent Drug
openFDA source record
Food
Class I
Ongoing
Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506
Firm: International Sprout Holdings, Inc
Reason: Potential E. coli and Salmonella contamination
openFDA source record
Drugs
Class I
Ongoing
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
Firm: Baxter Healthcare Corporation
Reason: Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
openFDA source record
Food
Class II
Ongoing
Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz
Firm: Ferrero USA
Reason: Undeclared milk and pecans
openFDA source record
Food
Class I
Ongoing
Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca Flour, Coconut Oil,...
Firm: EXOTIQUE FOODS CANADA
Reason: Undeclared Wheat.
openFDA source record
Food
Class II
Ongoing
Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass jar with white label and gold screw on closure. UPC: 50040360530
Firm: L-Nutra Inc
Reason: Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.
openFDA source record
Devices
Class II
Ongoing
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
Firm: Atrium Medical Corporation
Reason: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
openFDA source record
Devices
Class II
Ongoing
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Firm: Atrium Medical Corporation
Reason: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
openFDA source record
Devices
Class II
Ongoing
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber...
Firm: Lutronic Corporation
Reason: Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
openFDA source record
Devices
Class II
Ongoing
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Firm: Nipro Renal Soultions USA, Corporation
Reason: Hemodialysis concentrates contain high endotoxin levels
openFDA source record
Devices
Class II
Ongoing
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Firm: Nipro Renal Soultions USA, Corporation
Reason: Hemodialysis concentrates contain high endotoxin levels
openFDA source record
Devices
Class II
Ongoing
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Firm: Nipro Renal Soultions USA, Corporation
Reason: Hemodialysis concentrates contain high endotoxin levels
openFDA source record
Food
Class I
Ongoing
Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozen
Firm: EURO FOODS GROUP USA NJ INC
Reason: The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying.
openFDA source record
Devices
Class II
Ongoing
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Firm: Windstone Medical Packaging, Inc.
Reason: The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulati...
openFDA source record
Devices
Class II
Ongoing
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 050601671220...
Firm: HeartSine Technologies Ltd
Reason: Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
openFDA source record
Devices
Class II
Ongoing
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 1080174...
Firm: C.R. Bard Inc
Reason: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
openFDA source record
Devices
Class II
Ongoing
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921...
Firm: C.R. Bard Inc
Reason: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
openFDA source record
Devices
Class II
Ongoing
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray Syst...
Firm: C.R. Bard Inc
Reason: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
openFDA source record
Devices
Class II
Ongoing
Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley T...
Firm: C.R. Bard Inc
Reason: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
openFDA source record