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).
Lot #: 101301260605, BUD: 12/9/2026.
- Firm
- OurPharma LLC
- Quantity
- 1,610 bags
- 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.
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- Firm
- Ajanta Pharma USA Inc
- Quantity
- 403,200 tablets
- 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
Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
- Firm
- ImprimisRx NJ LLC
- Quantity
- 772 bottles
- 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
ISS Lot # SAL2-24JB
- Firm
- International Sprout Holdings, Inc
- Quantity
- 43,799 lbs.
- 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.
Lot #: Y495066, Exp. Date July 31, 2027
- Firm
- Baxter Healthcare Corporation
- Quantity
- 606 bags
- 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
All best by codes that were sold 8/7/2026 to 8/14/2026
- Firm
- Ferrero USA
- Quantity
- 1488 retail units
- 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.
Best Before: 2026 AUGUST 31
- Firm
- EXOTIQUE FOODS CANADA
- Quantity
- 68 cases
- 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.
Lot code: L2755 Expiration: 02 Jan 2027
- Firm
- L-Nutra Inc
- Quantity
- 8,529 jars
- 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.
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(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;
- Firm
- Atrium Medical Corporation
- Quantity
- 3618
- 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.
1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
- Firm
- Atrium Medical Corporation
- Quantity
- 256
- 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.
Lot Code: Model: DermaV Software Version: 1.06 UDI #: 08800291820200 Serial Numbers: DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015 DV025A016, DV025A018, DV025A019, DV025A020, DV025A021, DV025A022, DV025B011, DV025B012, DV025B013, DV025B014, DV025B015, DV025D006, DV025D007, DV025D008, DV025D009, DV025D010, DV025E003, DV025E004, DV025E005, DV025E006, DV025E007, DV025E008, DV025E009, DV025E010, DV025E011, DV025E012, DV025E013, DV025E014, DV025E016, DV025E017, DV025F012, DV025F013, DV025F014, DV025F0...
- Firm
- Lutronic Corporation
- Quantity
- 1065
- 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
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
- Firm
- Nipro Renal Soultions USA, Corporation
- Quantity
- 3,286 cases
- 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
DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
- Firm
- Nipro Renal Soultions USA, Corporation
- Quantity
- 2,327 cases
- 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
LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
- Firm
- Nipro Renal Soultions USA, Corporation
- Quantity
- 100 drums/1072 cases
- 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.
BATCH NO: 130 EF, 146 EF SERIAL NUMBER: 5055192640140 PRODUCT CODE: 28DSUM
- Firm
- EURO FOODS GROUP USA NJ INC
- Quantity
- 53 boxes
- 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.
UDI-DI:B098AMS12394B0; Lot Numbers: 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444, 237443, 236863, 236740, 236250, 236249, 236111, 235602, 235601, 235442, 235026, 235025, 235024, 235023, 234889, 234839, 234458, 233931, 233930, 233762, 233328, 233224, 231945, 231124, 231123, 231122, 231081, 231080, 230970, 230969, 230968, 230697, 230696, 230695, 230694, 230098, 229977, 229825, 229824, 229656, 229655, 229565, 229390, 2292...
- Firm
- Windstone Medical Packaging, Inc.
- Quantity
- 3,260 kits
- 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.
350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI codes: 0506016712067 Serial Numbers: 22D91164357L22 22D91164989L22 22D91180808K23 23D98000415K23 23D98000597K23 23D98001134L23 23D98001634I23 23D98001722F23 23D98002004K23 23D98002054K23 23D98002059I23 23D98002086L23 23D98002225K23 23D98002639K23 23D98002649K23 23D98002771L23 23D98002897K23 23D98003187A24 23D98003188L23 23D98003198F23 23D98003221K23 23D98003523K23 23D98004710K23 23D98004956L23 23D98005238E23 23D98005242K23 23D98008495L23 23D9800...
- Firm
- HeartSine Technologies Ltd
- Quantity
- 11,912
- 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.
Catalog Numbers / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611 899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610 899918 / 00801741024825¿ 10801741024822 Lot Number: NGKU3555 ***** SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Cathe...
- Firm
- C.R. Bard Inc
- Quantity
- 12,463 trays/kits
- 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.
Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 00801741024931¿ 10801741024938 Lot Numbers: NGKU0162 NGKU2507 947318 / 00801741024948¿ 10801741024945 Lot Numbers: NGKU2420 NGKU2865 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray 300416A / 00801741024580 10801741024587 Lot Numbers: NGKT1464 NGKU0129 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A300416A / 00801741073762...
- Firm
- C.R. Bard Inc
- Quantity
- 283883 trays/kits
- 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.
SureStep" Foley Tray System Add-A-Foley Catheter A153200 / 00801741121067¿ 10801741121064 Lot Number: NGKS2397 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A304400A / 00801741073847¿ 10801741073844 Lot Numbers: NGKU1023 NGKU3043 SureStep" Foley Tray System Add-A-Foley Catheter A399400 / 00801741100369¿ 10801741100366 Lot Number: NGKU2042 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A399400A / 00801741073915¿ 10801741073912 Lot Numbers: NGKT2456 NGKT3292 NGKU0999 NGKU1026 SureSt...
- Firm
- C.R. Bard Inc
- Quantity
- 33850 units/kits
- 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.
(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 Care¿ A300316AC / 00801741143250 Lot Number: NGKU2005 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516AMC / 00801741143472 Lot Number: NGKT2392 SureStep" Foley Tray System Bard¿ Lubricath Foley A800366C / 00801741143571 Lot Number: NGKT2413 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897514C / 008017410...
- Firm
- C.R. Bard Inc
- Quantity
- 364
- FDA IDs
- Z-3119-2026 / event 98840
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: Supernus P...
Failed dissolution specifications.
Lot# 2145283, Exp Date: 31-Mar-2030.
- Firm
- Supernus Pharmaceuticals, Inc.
- Quantity
- 11304 bottles
- FDA IDs
- D-0833-2026 / event 99767
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 Pharmaceuticals, Parsip...
Presence of Foreign Tablets/Capsules
Lot: 1394026, Exp. 02/2028.
- Firm
- Teva Pharmaceuticals USA, Inc
- Quantity
- 175,392 bottles
- FDA IDs
- D-0834-2026 / event 99734
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, (Individual...
Labeling: Label Mix-up
Lot # 1030023, Exp Date: 06/30/2027.
- Firm
- American Health Packaging
- Quantity
- 10,953 cartons.
- FDA IDs
- D-0840-2026 / event 99674
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, RIBOFLAVI...
Sesame is not declared in the ingredient statement but is declared in the statement of identity.
No codes
- Firm
- Prince Bakery Inc
- Quantity
- 150 units (total)
- FDA IDs
- H-1304-2026 / event 99646
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, FERROUS SULFATE...
Sesame is not declared in the ingredient statement but is declared in the statement of identity.
No codes
- Firm
- Prince Bakery Inc
- Quantity
- 150 units (total)
- FDA IDs
- H-1305-2026 / event 99646
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, Deerfield, IL, 600...
CGMP Deviations
Lot # NC193672, NC193795, Exp Date: 04/30/2028; Lot # NC194198, Exp Date: 05/31/2028.
- Firm
- Baxter Healthcare Corporation
- Quantity
- N/A
- FDA IDs
- D-0811-2026 / event 99500
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: Baxter Healthc...
CGMP Deviations
Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
- Firm
- Baxter Healthcare Corporation
- Quantity
- N/A
- FDA IDs
- D-0813-2026 / event 99500
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, Deerfield...
CGMP Deviations
Lot # NC185424, Exp Date: 2/12/2027; Lot # NC185479, Exp Date: 2/13/2027; Lot # NC193948, Exp Date: 10/23/2027.
- Firm
- Baxter Healthcare Corporation
- Quantity
- N/A
- FDA IDs
- D-0815-2026 / event 99500
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 Healthcare Co...
CGMP Deviations
Lot # NC193856, Exp Date: 04/18/2028.
- Firm
- Baxter Healthcare Corporation
- Quantity
- N/A
- FDA IDs
- D-0821-2026 / event 99500
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 - gallon jugs...
Product has high patulin levels
pull date/expiration date, etc. 7/17/26, 8/4/26, 8/13/26, 8/28/26, 9/4/26, 9/11/26, 9/30/26
- Firm
- WEIS MARKETS, INC.
- Quantity
- Pints : 360 , 1/2 Gallon : 855, Gallon - 765
- FDA IDs
- H-1308-2026 / event 99638
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 Use Only,...
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Lot#: LG342009076, Beyond Use Date: 10/4/26
- Firm
- OPTIMAL BALANCE PHARMACY
- Quantity
- 53 vials
- FDA IDs
- D-0851-2026 / event 99662
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
Foreign object: metal fragments
Best By 07/06/26 to Best By 08/03/26
- Firm
- Ukrop's Homestyle Foods LLC
- Quantity
- 150/4lb units
- FDA IDs
- H-1327-2026 / event 99548
Food
Class III
Ongoing
Reported Sep 9, 2026
Wonton Specialist Inc. Pan Fried Noodle, 16 oz and 5lb packaged in clear plastic bags
Undeclared FD&C Red No. 40
No codes.
- Firm
- Wonton Specialists
- Quantity
- 500 bags
- FDA IDs
- H-1320-2026 / event 99508
Food
Class III
Ongoing
Reported Sep 9, 2026
Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bags
Undeclared FD&C Red No. 40
No codes.
- Firm
- Wonton Specialists
- Quantity
- 700 bags
- FDA IDs
- H-1325-2026 / event 99508
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 preserved by...
Undeclared milk.
All batch codes.
- Firm
- Fayus Inc.
- Quantity
- Unknown
- FDA IDs
- H-1329-2026 / event 99368