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Recalls affecting Hawaii

Data last updated: September 11, 2026 at 1:08 PM UTC

16,303 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2025

Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98288
Lot/product code:
Model No. Model No. A22041A; UDI: 04042761020961; All Lots.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2025

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

Devices are not suitable for organ transplant.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98060
Lot/product code:
Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2025

Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98288
Lot/product code:
Model No. A2666; UDI: 04042761004244; All Lots
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2025

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.

Devices are not suitable for organ transplant.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98060
Lot/product code:
Kit Code: LLOG1000-15; UDI: 10809160432679; Lot No: 1632138 & 1648393.
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2025

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

Devices are not suitable for organ transplant.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98060
Lot/product code:
Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 11, 2025

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

Weaker than it should be drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0219-2026
Lot/product code:
Lot # F2400244, Exp Date: 10/31/2026
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2025

Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98288
Lot/product code:
Model No. A2660T; UDI: 04042761004183; All Lots.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2025

Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98288
Lot/product code:
Model No. WA22017A; UDI: 04042761051514; All Lots.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 10, 2025

ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97923
Lot/product code:
Model/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers;
Recalling firm:
Draeger, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 10, 2025

ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97923
Lot/product code:
Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;
Recalling firm:
Draeger, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 10, 2025

ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97923
Lot/product code:
Model/Catalog Number: MP01840; UDI Number:04048675420736; Lot numbers: All lot numbers
Recalling firm:
Draeger, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 10, 2025

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97992
Lot/product code:
Catalog Numbers: COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 UDI-DI code: 15099590233686 Lot Numbers: 2510410 2510420 2510450 3557500 3557510 3557540 3557560 3557570 3557640 3557650 3557660 3557670 3557680 3557700 3557710 3557850 3557920 3557930 3558000 3558030 3558040 3558060 3558090 3558100 3558110 3558120 3558140 3558150 3558160 3558170
Recalling firm:
Beckman Coulter, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 10, 2025

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97923
Lot/product code:
Model/Catalog Number: MP01845; UDI Number: 04048675420729; Lot numbers: All lot numbers;
Recalling firm:
Draeger, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusBotulismRecalled November 8, 2025

1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2. ByHeart Whole Nutrition Infant Formula Anywhere Packs Single Serve Packet 17 grams in packages containing 14 Single Serve Packets

Contaminated with Clostridium botulinum

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0249-2026
Lot/product code:
All batches and codes within expiry Finished Product Quantity 08NOV2023 to 08NOV2025 UPC Codes: Single Can: 8 50044 96800 8; Sams Club 2PK: 00850044968893; Amazon 2PK: 00850044968053; Anywhere pack: 8 50044 96802 2; 1-Count Sample Unit Anywhere Pack: 850044968015
Recalling firm:
ByHeart, INC.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 7, 2025

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.

Defective Container - A defect in the side-seal which allows leakage of product.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0198-2026
Lot/product code:
Lot #100068692, Exp.: 04/30/2027
Recalling firm:
Teva Pharmaceuticals USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 7, 2025

Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97932
Lot/product code:
UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005
Recalling firm:
Beckman Coulter, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97985
Lot/product code:
Lot# NGJU4181/UDI: (01)00801741015687
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97985
Lot/product code:
Lot# NGJU4163/UDI: (01)00801741015403
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,

Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97864
Lot/product code:
UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.

Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97871
Lot/product code:
Catalog Number: 8100 Material Number: 8100BDBDXEN1212 UDI-DI code: 10885403810046 Equipment/Software Version: 8100BD PUMP MODULE V12.1.2 DOM V12.1.2 Serial Numbers: 17377484 17377907 17377935 17377939 17377942 17377946 17377948 17377952 17377959 17377961 17377965 17377970 17377972 17377973 17377976 17377978 17377980 17377987 17377992 17377993 17378071 17378072 17378073 17378074 17378075 17378079 17378081 17378082 17378084 17378085 17378086 17378087 17378088 17378089 17378090 17378091 17378092 17378093 17378094 17378095 17378096 17378098 17378099 17378101 17378102 17378103 17378124 17378125 17378126 17378127 17378145 17378147 17378149 17378153 17378154 17378156 17378157 17378158 17378163 17378164 17378166 17378167 17378168 17378170 17378172 17378176 17378178 17378179 17378180 17378181 17378182 17378183 17378184 17378185 17378186 17378187 17378188 17378189 17378190 17378193 17378194 17378196 17378198 17378199 17378201 17378203 17378205 17378207 17378209 17378221 17378222 17378223 17378224 17378225 17378226 17378227 17378236 17378239 17378240 17378241 17378242 17378243 17378244 17378245 17378246 17378247 17378248 17378249 17378267 17378268 17378269 17378270 17378271 17378272 17378279 17378281 17378282 17378286 17378287 17378288 17378289 17378290 17378293 17378296 17378298 17378303 17378305 17378309 17378310 17378312 17378314 17378315 17378316 17378317 17378318 17378319 17378320 17378321 17378333 17378334 17378335 17378336 17378337 17378338 17378339 17378347 17378349 17378363 17378364 17378365 17378366 17378367 17378369 17378370 17378371 17378375 17378377 17378395 17378396 17378401 17378402 17378403 17378405 17378408 17378424 17378433 17378434 17378435 17378444 17378445 17378447 17378449 17378452 17378454 17378455 17378465 17378466 17378467 17378481 17378482 17378483 17378484 17378485 17378497 17378499 17378502 17378503 17378505 17378506
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97985
Lot/product code:
Lot# NGJU4328/UDI: (01)00801741015922
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 6, 2025

BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97985
Lot/product code:
Lot# NGJU4327/UDI:(01)00801741015786
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled November 6, 2025

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0182-2026
Lot/product code:
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 5, 2025

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Safety and efficacy of dialysis acid concentrate cannot be assured

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
97989
Lot/product code:
UDI: None/Lot Code: PHV08042
Recalling firm:
Diasol, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 5, 2025

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

Defective container - seal not adhering to bottles

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0227-2026
Lot/product code:
Lot # QB00865, exp. date Feb 2028
Recalling firm:
Lupin Pharmaceuticals Inc.
View official FDA record (opens in a new tab)