Recall Reason Clues

A no-JavaScript view of the FDA reason-for-recall field in the latest loaded openFDA recall snapshot. Use this when the problem description matters: contamination, sterility, undeclared ingredients, device issues, labeling mistakes, or other hazards. Reason text is a clue, not a diagnosis or match by itself, so confirm product, firm, code, location, and source record details before acting. For private comparison, use the match checker; for product names, use product clues; for label details, use code clues; for broader browsing, use the latest digest.

GeneratedSep 23, 2026, 8:30 PM EDT
Reason Records36
Class I6
Categories3
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).

Firm
OurPharma LLC
Codes
Lot #: 101301260605, BUD: 12/9/2026.
Distribution
Nationwide within the U.S
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Ajanta Pharma USA Inc
Codes
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Distribution
Nationwide within the U.S
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
ImprimisRx NJ LLC
Codes
Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
Distribution
USA Nationwide
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
International Sprout Holdings, Inc
Codes
ISS Lot # SAL2-24JB
Distribution
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
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Baxter Healthcare Corporation
Codes
Lot #: Y495066, Exp. Date July 31, 2027
Distribution
U.S. Nationwide.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
EXOTIQUE FOODS CANADA
Codes
Best Before: 2026 AUGUST 31
Distribution
Product was sold in the U.S.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
L-Nutra Inc
Codes
Lot code: L2755 Expiration: 02 Jan 2027
Distribution
Product is sold exclusively from the recalling firm's online website nationwide.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Atrium Medical Corporation
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...
Distribution
US Nationwide distribution.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Atrium Medical Corporation
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;
Distribution
US Nationwide distribution.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Lutronic Corporation
Codes
Lot Code: Model: DermaV Software Version: 1.06 UDI #: 08800291820200 Serial Numbers: DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015 DV025A016, DV025A018, DV025A01...
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and European Union.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
Devices Class II Ongoing Reported Sep 16, 2026

MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

Hemodialysis concentrates contain high endotoxin levels

Firm
Nipro Renal Soultions USA, Corporation
Codes
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
Distribution
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.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
Nipro Renal Soultions USA, Corporation
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)
Distribution
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.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
Nipro Renal Soultions USA, Corporation
Codes
LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
Distribution
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.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
EURO FOODS GROUP USA NJ INC
Codes
BATCH NO: 130 EF, 146 EF SERIAL NUMBER: 5055192640140 PRODUCT CODE: 28DSUM
Distribution
The adulterated product was distributed to the following states: VA, NY, NJ, MI
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Windstone Medical Packaging, Inc.
Codes
UDI-DI:B098AMS12394B0; Lot Numbers: 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444,...
Distribution
US Nationwide distribution in the states of CA, GA, WA.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
HeartSine Technologies Ltd
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...
Distribution
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, P...
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
C.R. Bard Inc
Codes
Catalog Numbers / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611 899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610 899918 / 0080174102...
Distribution
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,...
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
C.R. Bard Inc
Codes
Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 0080174102...
Distribution
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,...
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
C.R. Bard Inc
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...
Distribution
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,...
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
C.R. Bard Inc
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...
Distribution
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,...
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Supernus Pharmaceuticals, Inc.
Codes
Lot# 2145283, Exp Date: 31-Mar-2030.
Distribution
US Nationwide.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
Teva Pharmaceuticals USA, Inc
Codes
Lot: 1394026, Exp. 02/2028.
Distribution
U.S. Nationwide
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
American Health Packaging
Codes
Lot # 1030023, Exp Date: 06/30/2027.
Distribution
US Nationwide.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Prince Bakery Inc
Codes
No codes
Distribution
New York.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Prince Bakery Inc
Codes
No codes
Distribution
New York.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
Baxter Healthcare Corporation
Codes
Lot # NC193672, NC193795, Exp Date: 04/30/2028; Lot # NC194198, Exp Date: 05/31/2028.
Distribution
US Nationwide; Puerto Rico; and Chile.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
Baxter Healthcare Corporation
Codes
Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
Distribution
US Nationwide; Puerto Rico; and Chile.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
Baxter Healthcare Corporation
Codes
Lot # NC185424, Exp Date: 2/12/2027; Lot # NC185479, Exp Date: 2/13/2027; Lot # NC193948, Exp Date: 10/23/2027.
Distribution
US Nationwide; Puerto Rico; and Chile.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
Baxter Healthcare Corporation
Codes
Lot # NC193856, Exp Date: 04/18/2028.
Distribution
US Nationwide; Puerto Rico; and Chile.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
WEIS MARKETS, INC.
Codes
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
Distribution
The recalled product was distributed to the State of PA.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
OPTIMAL BALANCE PHARMACY
Codes
Lot#: LG342009076, Beyond Use Date: 10/4/26
Distribution
USA Nationwide.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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

Firm
Ukrop's Homestyle Foods LLC
Codes
Best By 07/06/26 to Best By 08/03/26
Distribution
Product was shipped to the following states: KY, NC, VA & WVA.
Source
openFDA source record
Search this reason in Recall Radar Check this product privately
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.

Firm
Fayus Inc.
Codes
All batch codes.
Distribution
Domestic: CA, GA, IL, NJ, NY, TX Foreign: Canada, Australia
Source
openFDA source record
Search this reason in Recall Radar Check this product privately