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.
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).
Nationwide within the U.S
- Firm
- OurPharma LLC
- Recall began
- Sep 3, 2026
- Quantity
- 1,610 bags
- Codes
- Lot #: 101301260605, BUD: 12/9/2026.
- FDA IDs
- Not specified / event 99837
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.
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.
Nationwide within the U.S
- Firm
- Ajanta Pharma USA Inc
- Recall began
- Aug 25, 2026
- Quantity
- 403,200 tablets
- Codes
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- FDA IDs
- D-0836-2026 / event 99733
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, Ledgewood, NJ 078...
Subpotent Drug
USA Nationwide
- Firm
- ImprimisRx NJ LLC
- Recall began
- Aug 24, 2026
- Quantity
- 772 bottles
- Codes
- Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
- FDA IDs
- D-0835-2026 / event 99756
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
Potential E. coli and Salmonella contamination
Wholesale consignees in 16 states: CA, FL, HI, IL, MA, MN, MO, MT, NY, OH, OR, PA, TN, SC, TX, UT; Puerto Rico; Canada, Mexico, Tahiti, and Venezuela
- Firm
- International Sprout Holdings, Inc
- Recall began
- Aug 23, 2026
- Quantity
- 43,799 lbs.
- Codes
- ISS Lot # SAL2-24JB
- FDA IDs
- H-1341-2026 / event 99822
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
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
U.S. Nationwide.
- Firm
- Baxter Healthcare Corporation
- Recall began
- Aug 17, 2026
- Quantity
- 606 bags
- Codes
- Lot #: Y495066, Exp. Date July 31, 2027
- FDA IDs
- D-0850-2026 / event 99679
Food
Class II
Ongoing
Reported Sep 16, 2026
Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz
Undeclared milk and pecans
IA, IL, IN, OH
- Firm
- Ferrero USA
- Recall began
- Aug 14, 2026
- Quantity
- 1488 retail units
- Codes
- All best by codes that were sold 8/7/2026 to 8/14/2026
- FDA IDs
- H-1334-2026 / event 99682
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, Salt, Whit...
Undeclared Wheat.
Product was sold in the U.S.
- Firm
- EXOTIQUE FOODS CANADA
- Recall began
- Aug 7, 2026
- Quantity
- 68 cases
- Codes
- Best Before: 2026 AUGUST 31
- FDA IDs
- H-1330-2026 / event 99636
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
Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.
Product is sold exclusively from the recalling firm's online website nationwide.
- Firm
- L-Nutra Inc
- Recall began
- Aug 7, 2026
- Quantity
- 8,529 jars
- Codes
- Lot code: L2755 Expiration: 02 Jan 2027
- FDA IDs
- H-1335-2026 / event 99675
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);
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
US Nationwide distribution.
- Firm
- Atrium Medical Corporation
- Recall began
- Aug 7, 2026
- Quantity
- 3618
- Codes
- 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Si...
- FDA IDs
- Z-3111-2026 / event 99680
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);
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
US Nationwide distribution.
- Firm
- Atrium Medical Corporation
- Recall began
- Aug 7, 2026
- Quantity
- 256
- Codes
- 1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
- FDA IDs
- Z-3113-2026 / event 99680
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-optic han...
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Worldwide distribution - US Nationwide and the countries of Canada and European Union.
- Firm
- Lutronic Corporation
- Recall began
- Aug 6, 2026
- Quantity
- 1065
- Codes
- Lot Code: Model: DermaV Software Version: 1.06 UDI #: 08800291820200 Serial Numbers: DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015 DV025A016, DV025A018, DV025A01...
- FDA IDs
- Z-3110-2026 / event 99601
Devices
Class II
Ongoing
Reported Sep 16, 2026
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Hemodialysis concentrates contain high endotoxin levels
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
- Firm
- Nipro Renal Soultions USA, Corporation
- Recall began
- Aug 5, 2026
- Quantity
- 3,286 cases
- Codes
- BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
- FDA IDs
- Z-3133-2026 / event 99573
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))
Hemodialysis concentrates contain high endotoxin levels
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
- Firm
- Nipro Renal Soultions USA, Corporation
- Recall began
- Aug 5, 2026
- Quantity
- 2,327 cases
- Codes
- DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
- FDA IDs
- Z-3134-2026 / event 99573
Devices
Class II
Ongoing
Reported Sep 16, 2026
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Hemodialysis concentrates contain high endotoxin levels
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
- Firm
- Nipro Renal Soultions USA, Corporation
- Recall began
- Aug 5, 2026
- Quantity
- 100 drums/1072 cases
- Codes
- LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
- FDA IDs
- Z-3136-2026 / event 99573
Food
Class I
Ongoing
Reported Sep 16, 2026
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.
The adulterated product was distributed to the following states: VA, NY, NJ, MI
- Firm
- EURO FOODS GROUP USA NJ INC
- Recall began
- Aug 1, 2026
- Quantity
- 53 boxes
- Codes
- BATCH NO: 130 EF, 146 EF SERIAL NUMBER: 5055192640140 PRODUCT CODE: 28DSUM
- FDA IDs
- H-1331-2026 / event 99684
Devices
Class II
Ongoing
Reported Sep 16, 2026
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
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 manipulation.
US Nationwide distribution in the states of CA, GA, WA.
- Firm
- Windstone Medical Packaging, Inc.
- Recall began
- Jul 29, 2026
- Quantity
- 3,260 kits
- Codes
- UDI-DI:B098AMS12394B0; Lot Numbers: 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444,...
- FDA IDs
- Z-3138-2026 / event 99658
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: 0506016712207 350P US...
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia,...
- Firm
- HeartSine Technologies Ltd
- Recall began
- Jul 27, 2026
- Quantity
- 11,912
- Codes
- 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI codes: 0506016712067 Serial Numbers: 22D91164357L22 22D91164989L22 22D91180808K23 23D98000415K23 23D98000597K...
- FDA IDs
- Z-3120-2026 / event 99568
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¿ 10801741024815 00...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...
- Firm
- C.R. Bard Inc
- Recall began
- Jun 25, 2026
- Quantity
- 12,463 trays/kits
- Codes
- Catalog Numbers / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611 899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610 899918 / 0080174102...
- FDA IDs
- Z-3114-2026 / event 98840
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 008017410...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...
- Firm
- C.R. Bard Inc
- Recall began
- Jun 25, 2026
- Quantity
- 283883 trays/kits
- Codes
- Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 0080174102...
- FDA IDs
- Z-3115-2026 / event 98840
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 System Complet...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...
- Firm
- C.R. Bard Inc
- Recall began
- Jun 25, 2026
- Quantity
- 33850 units/kits
- Codes
- SureStep" Foley Tray System Add-A-Foley Catheter A153200 / 00801741121067¿ 10801741121064 Lot Number: NGKS2397 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A3044...
- FDA IDs
- Z-3118-2026 / event 98840
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 Tray System...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...
- Firm
- C.R. Bard Inc
- Recall began
- Jun 25, 2026
- Quantity
- 364
- Codes
- (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 Lot Number: NGKT2492 SureStep" Foley Tray System Bardex¿ IC Complete...
- FDA IDs
- Z-3119-2026 / event 98840