Drugs
Not Yet Classified
Ongoing
Reported Sep 16, 2026
OurPharma LLC
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.
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).
Drugs
Class III
Ongoing
Reported Sep 16, 2026
Ajanta Pharma USA Inc
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.
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.
Drugs
Class III
Ongoing
Reported Sep 16, 2026
ImprimisRx NJ LLC
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, Ledgewood, NJ 07852, NDC 71384-732-10
Subpotent Drug
Food
Class I
Ongoing
Reported Sep 16, 2026
International Sprout Holdings, Inc
Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506
Potential E. coli and Salmonella contamination
Drugs
Class I
Ongoing
Reported Sep 16, 2026
Baxter Healthcare Corporation
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Food
Class II
Ongoing
Reported Sep 16, 2026
Ferrero USA
Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz
Undeclared milk and pecans
Food
Class I
Ongoing
Reported Sep 16, 2026
EXOTIQUE FOODS CANADA
Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca Flour, Coconut Oil, Salt, White Pepper. Proudly Made in Indonesia. Imp...
Undeclared Wheat.
Food
Class II
Ongoing
Reported Sep 16, 2026
L-Nutra Inc
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
Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Atrium Medical Corporation
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);
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Lutronic Corporation
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-optic handpiece. The system may be configured wit...
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Nipro Renal Soultions USA, Corporation
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Hemodialysis concentrates contain high endotoxin levels
Food
Class I
Ongoing
Reported Sep 16, 2026
EURO FOODS GROUP USA NJ INC
Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozen
The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying.