Sep 3, 2026
1 loaded recalls began on this date. 0 Class I. 1 ongoing.
Drugs
Not Yet Classified
Ongoing
Reported Sep 16, 2026
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
Aug 31, 2026
1 loaded recalls began on this date. 0 Class I. 1 ongoing.
Drugs
Class III
Ongoing
Reported Sep 9, 2026
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for:...
Firm: Supernus Pharmaceuticals, Inc.
Reason: Failed dissolution specifications.
openFDA source record
Aug 25, 2026
1 loaded recalls began on this date. 0 Class I. 1 ongoing.
Drugs
Class III
Ongoing
Reported Sep 16, 2026
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
Aug 24, 2026
2 loaded recalls began on this date. 0 Class I. 2 ongoing.
Drugs
Class III
Ongoing
Reported Sep 16, 2026
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
Drugs
Class II
Ongoing
Reported Sep 9, 2026
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceutica...
Firm: Teva Pharmaceuticals USA, Inc
Reason: Presence of Foreign Tablets/Capsules
openFDA source record
Aug 23, 2026
1 loaded recalls began on this date. 1 Class I. 1 ongoing.
Food
Class I
Ongoing
Reported Sep 16, 2026
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
Aug 19, 2026
1 loaded recalls began on this date. 0 Class I. 1 ongoing.
Drugs
Class III
Ongoing
Reported Sep 9, 2026
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (I...
Firm: American Health Packaging
Reason: Labeling: Label Mix-up
openFDA source record
Aug 17, 2026
1 loaded recalls began on this date. 1 Class I. 1 ongoing.
Drugs
Class I
Ongoing
Reported Sep 16, 2026
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
Aug 14, 2026
1 loaded recalls began on this date. 0 Class I. 1 ongoing.
Food
Class II
Ongoing
Reported Sep 16, 2026
Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz
Firm: Ferrero USA
Reason: Undeclared milk and pecans
openFDA source record
Aug 13, 2026
2 loaded recalls began on this date. 0 Class I. 2 ongoing.
Food
Class III
Ongoing
Reported Sep 9, 2026
Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE,...
Firm: Prince Bakery Inc
Reason: Sesame is not declared in the ingredient statement but is declared in the statement of identity.
openFDA source record
Food
Class III
Ongoing
Reported Sep 9, 2026
Prince ITALIAN BREAD; Sesame; ITALIAN & FRENCH BREAD, LARGE; NET WEIGHT 12 OZ. (340g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERRO...
Firm: Prince Bakery Inc
Reason: Sesame is not declared in the ingredient statement but is declared in the statement of identity.
openFDA source record
Aug 7, 2026
4 loaded recalls began on this date. 1 Class I. 4 ongoing.
Food
Class I
Ongoing
Reported Sep 16, 2026
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
Reported Sep 16, 2026
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
Reported Sep 16, 2026
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
Reported Sep 16, 2026
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
Aug 6, 2026
6 loaded recalls began on this date. 0 Class I. 6 ongoing.
Devices
Class II
Ongoing
Reported Sep 16, 2026
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
Drugs
Class II
Ongoing
Reported Sep 9, 2026
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfiel...
Firm: Baxter Healthcare Corporation
Reason: CGMP Deviations
openFDA source record
Drugs
Class II
Ongoing
Reported Sep 9, 2026
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxt...
Firm: Baxter Healthcare Corporation
Reason: CGMP Deviations
openFDA source record
Drugs
Class II
Ongoing
Reported Sep 9, 2026
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation,...
Firm: Baxter Healthcare Corporation
Reason: CGMP Deviations
openFDA source record
Drugs
Class II
Ongoing
Reported Sep 9, 2026
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Hea...
Firm: Baxter Healthcare Corporation
Reason: CGMP Deviations
openFDA source record
Food
Class II
Ongoing
Reported Sep 9, 2026
Weis (Fresh From the Orchard ) Pasteurized Apple Cider, Contains 100 % Juice, the product comes in the following sizes: Pints, 1/2 Gallon, Gallon, plastic jug. 6 1/2 - ga...
Firm: WEIS MARKETS, INC.
Reason: Product has high patulin levels
openFDA source record
Aug 5, 2026
4 loaded recalls began on this date. 1 Class I. 4 ongoing.
Devices
Class II
Ongoing
Reported Sep 16, 2026
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
Reported Sep 16, 2026
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
Reported Sep 16, 2026
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
Drugs
Class I
Ongoing
Reported Sep 9, 2026
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection...
Firm: OPTIMAL BALANCE PHARMACY
Reason: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
openFDA source record
Aug 1, 2026
1 loaded recalls began on this date. 1 Class I. 1 ongoing.
Food
Class I
Ongoing
Reported Sep 16, 2026
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
Jul 30, 2026
1 loaded recalls began on this date. 0 Class I. 1 ongoing.
Food
Class II
Ongoing
Reported Sep 9, 2026
Bread Pudding with Vanilla Sauce - KIT NET WT 4 LB (1.81Kg) UPC 7 22515 91732 0 Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Firm: Ukrop's Homestyle Foods LLC
Reason: Foreign object: metal fragments
openFDA source record
Jul 29, 2026
1 loaded recalls began on this date. 0 Class I. 1 ongoing.
Devices
Class II
Ongoing
Reported Sep 16, 2026
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
Jul 28, 2026
2 loaded recalls began on this date. 0 Class I. 2 ongoing.
Food
Class III
Ongoing
Reported Sep 9, 2026
Wonton Specialist Inc. Pan Fried Noodle, 16 oz and 5lb packaged in clear plastic bags
Firm: Wonton Specialists
Reason: Undeclared FD&C Red No. 40
openFDA source record
Food
Class III
Ongoing
Reported Sep 9, 2026
Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bags
Firm: Wonton Specialists
Reason: Undeclared FD&C Red No. 40
openFDA source record
Jul 27, 2026
1 loaded recalls began on this date. 0 Class I. 1 ongoing.
Devices
Class II
Ongoing
Reported Sep 16, 2026
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
Jul 6, 2026
1 loaded recalls began on this date. 1 Class I. 1 ongoing.
Food
Class I
Ongoing
Reported Sep 9, 2026
OLA-OLA Pounded Yam (Iyan) IYANINSTANT, NET WT. 2 lbs., 4 lbs., 5 lbs., 10 lbs, packed in flexible plastic bags. INGREDIENTS: Processed Dehydrated Yam Flour, freshness pr...
Firm: Fayus Inc.
Reason: Undeclared milk.
openFDA source record
Jun 25, 2026
4 loaded recalls began on this date. 0 Class I. 4 ongoing.
Devices
Class II
Ongoing
Reported Sep 16, 2026
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
Reported Sep 16, 2026
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
Reported Sep 16, 2026
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
Reported Sep 16, 2026
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