Recalls & alerts

1278 alerts recorded, refreshed every six hours. Filter by source or category.

• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY…

  Medline Industries is recalling certain Medline Convenience Kits, including IV start kits, blood culture kits, and pediatric emergency trays, with specific catalog numbers. The kits contain BD ChloraPrep Clear and FREPP Clear applicators that may have a sterility breach due to wrinkles in the paper lidding, exposing patients and users to microbial contamination and possible infection. Consumers should stop using the affected kits and contact Medline Industries for instructions.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT…

  Medline Industries is recalling certain Convenience Kits, including Eye Kit models DYKM2751 and DYKM2751A and Cataract Preop Kit models DYKS1583A and DYKS1583B. The kits contain applicators with a possible sterility breach that could expose patients and users to microbial contamination, risking infection. Consumers should stop using the affected kits and contact Medline Industries for instructions.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2)…

  Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays, including specific catalog numbers. The wipes may be contaminated with a lubricant, causing localized skin irritation, erythema, or mild inflammation in patients. Consumers should stop using the affected trays and contact Cardinal Health for further instructions.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number:…

  Medline Industries is recalling several Medline Convenience Kits, including IV Start and IV Blood Culture kits, with specific model numbers. The kits contain applicators whose packaging may have a sterility breach, exposing patients and users to microbial contamination that could cause infection. Consumers should check the recalled model numbers and follow the firm's recall instructions.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A…

  Medline is recalling certain Convenience Kits that contain BD ChloraPrep Clear 1mL Applicators. The applicator packaging may have an open or incomplete seal, risking contamination and possible skin, soft tissue, or systemic infection for patients. Consumers should stop using affected kits, check the recalled lot numbers, and contact Medline for replacement or return.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

  Fresenius Medical Care Renal Therapies Group, LLC is recalling its 5008X HD/HDF Standard Blood Tubing Set, part number 03-5300-3. The tubing can leak blood at the connection between the Arterial Alpha Clip and the main line or pump segment, risking blood loss and hypovolemia for dialysis patients. Consumers should stop using the affected sets and contact Fresenius Medical Care for replacement instructions.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B

  Medline Industries is recalling its Medline Convenience Kit C-SECTION PREP, model DYNJ32702B. The kits contain applicators with a possible sterility breach, exposing patients and users to microbial contamination that could cause infection. Consumers should stop using the affected kits and follow the recall instructions from Medline or the FDA.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST ,…

  Cardinal Health Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays are affected. The wipes may be contaminated with a lubricant, which can cause skin irritation, redness, or mild inflammation in patients. Consumers should check for the recalled catalog numbers and contact Cardinal Health for instructions.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate…

  Fresenius Medical Care Renal Therapies Group, LLC is recalling Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis with product numbers 08-2251-CA, 08-3251-CA, and 13-2251-CA. The product may have blue-green discoloration, posing a hazard to patients undergoing hemodialysis. Consumers should check their product numbers and follow the recall instructions from the company.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR…

  Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes inside BD Urinary Catheter Trays, with specific catalog numbers. The wipes may be contaminated with a manufacturing lubricant, posing a risk of skin irritation, erythema, or mild inflammation to patients. Consumers should identify affected catalog numbers and follow the voluntary recall instructions from Cardinal Health.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0,…

  Fresenius Medical Care is recalling NaturaLyte, a liquid acid concentrate for bicarbonate hemodialysis, with specific product numbers. The product may show blue-green discoloration, posing a risk to patients receiving dialysis. Consumers should stop using the affected product and follow the recall instructions.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL

  The affected product is the Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL. A software issue during multi-syringe infusion when a syringe is replaced while volume remains poses a hazard to patients using the pump. The recall is voluntary and firm-initiated, so consumers should follow the recall notice.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB

  Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators (OPEN HEART CDS983348AA and CDS983348AB) are affected. The applicator packaging may have an open or incomplete seal, exposing patients to risk of skin, soft tissue, or systemic infection. Consumers should stop using affected kits and contact Medline Industries for instructions.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

  Baxter Healthcare Corporation is recalling its Novum IQ Syringe Pump, model 40800BAXUS. A software issue during multi-syringe infusion can cause incorrect delivery when a syringe is replaced, posing a risk to patients. Consumers should contact Baxter Healthcare Corporation for instructions.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F

  Medline Industries, LP is recalling two Convenience Kits: LABOR CDS (CDS981762B) and VAG DELIVERY ADMISSION BAG (DYKA1054F). The kits contain applicators with packaging that may lose sterility, exposing patients and users to microbial contamination that could cause infection. Consumers should stop using the affected kits and follow the recall instructions.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A

  Medline Industries is recalling its Convenience Kits containing BD ChloraPrep Clear 1mL Applicators, specifically the Cataract Preop Kit DYKS1583A. The applicator packaging may have an open or incomplete seal, exposing patients to contamination that could cause skin, soft tissue, or systemic infections. Consumers should stop using affected kits and contact Medline or their healthcare provider for instructions.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C

  Medline Industries is recalling its Medline Convenience Kit ULTRASOUND BREAST PACK, model DYNJ63375C. The kits contain applicators with a potential sterility breach, exposing patients and users to microbial contamination and possible infection. The recall is voluntary and firm-initiated, with no specific consumer action listed in the notice.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4)…

  Medline Convenience Kits with catalog numbers DYKM1414, DYNDH1462A, DYNJ38145F, and DYNJ63199A are affected. The kits contain applicators with a potential breach of sterility, exposing patients and users to microbial contamination that may cause infection. Consumers should stop using the affected kits and contact Medline Industries for instructions.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis

  Fresenius Medical Care Renal Therapies Group is recalling its GRANUFLO Dry Acid Concentrate, product numbers 0FD2251-3B and 0FD3251-3B, used for bicarbonate hemodialysis. The product may have blue-green discoloration, posing a potential hazard to patients undergoing dialysis. Consumers should check their product numbers and contact Fresenius Medical Care for instructions.

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• openFDA · September 9, 2026Moderate risk

  Medos International Sarl : Velys Enabling Tech Robotic-Assist Station REF: 451611001

  Medos International Sarl is recalling the Velys Enabling Tech Robotic-Assist Station, model REF 451611001. A software issue can cause unintended movement of the robotic arm during surgery, exposing patients to injury. Consumers should stop using the device and contact Medos International for instructions.

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• openFDA · September 9, 2026Moderate risk

  Philips North America Llc : Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x

  Philips is recalling certain Ingenuity CT systems with software version 4.4.10.x, including specific product codes. The systems may deliver unintended radiation, which could affect patients during scans. Patients should contact their healthcare provider or Philips for further instructions.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

  The recall affects Fresenius Medical Care Renal Therapies Group's 5008X Standard HD Pre-Flush Standard Blood Tubing Set, part number 03-5110-6. A blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment can cause blood loss and hypovolemia during treatment. Consumers should consult the FDA recall notice for instructions from the firm's voluntary recall.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD…

  Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators are recalled. The applicator packaging may have an open or incomplete seal, risking contamination and infection for patients. Consumers should stop using affected kits and contact Medline for return or replacement.

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• openFDA · September 9, 2026Moderate risk

  AVID Medical, Inc. : Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item…

  AVID Medical, Inc. is recalling Halyard medical convenience kits for ENT, back, spine, nasal, and other procedures. The kits contain Ritmed Neurological Sponges with potentially variable endotoxin levels, exposing patients to risk. Consumers should stop using the affected kits and contact AVID Medical for instructions.

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• openFDA · September 9, 2026Moderate risk

  Philips North America Llc : Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x

  Philips Brilliance CT 64 systems with software 4.1.10.x are affected. An unintended radiation issue could affect equipment performance, exposing patients to risk. Consumers should follow the FDA recall notice for guidance.

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• openFDA · September 9, 2026Moderate risk

  Boston Scientific Corporation : LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)

  Boston Scientific is recalling its LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor System server software, model 7260, all versions. The software may delay AF Burden Alert notifications, which could delay clinical evaluation or treatment for patients with these monitors. Patients should contact their healthcare provider to discuss the potential delay and any needed follow-up.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D

  Cardinal Health is recalling Presource Packs containing CliniClean Pericare Wipes inside BD Urinary Catheter Trays, catalog PWV2MF01D. The wipes may be contaminated with manufacturing lubricant, causing skin irritation, redness, or mild inflammation in patients. Consumers should stop using the affected packs and contact Cardinal Health for return and replacement instructions.

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• openFDA · September 9, 2026Moderate risk

  Johnson & Johnson Surgical Vision, Inc. : HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF:…

  Johnson & Johnson Surgical Vision is recalling HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products used in cataract surgery. Forcing the cannula during insertion can cause corneal abrasion, iris trauma, or detachment of Descemet's membrane in patients. Consumers should follow the updated surgical instructions and withdraw and reassess the cannula if resistance is met, never forcing it.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST ,…

  Cardinal Health is recalling Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays, including robotic hysterectomy and C-section kits. The wipes may be contaminated with manufacturing lubricant, causing skin irritation, redness, or mild inflammation in patients. Consumers should stop using the affected trays and contact Cardinal Health for instructions.

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• openFDA · September 9, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

  The recall affects Fresenius Medical Care's 5008X HD/HDF with Twister Blood Tubing Set, part number 03-5350-8. A blood leak may occur at the connection between the Arterial Alpha Clip and the main line or pump segment, exposing patients to blood loss and hypovolemia during treatment. Consumers should follow the firm's voluntary recall instructions for this product.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT…

  Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays, listed under multiple catalog numbers. The wipes may be contaminated with manufacturing lubricant, causing localized skin irritation, erythema, or mild inflammation in patients. Consumers should check the recalled catalog numbers and contact Cardinal Health for return or replacement instructions.

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• openFDA · September 9, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog…

  Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes inside BD Urinary Catheter Trays. The wipes may be contaminated with a lubricant, causing skin irritation, redness, or mild inflammation in patients. Consumers should stop using the affected wipes and contact Cardinal Health for instructions.

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• openFDA · September 9, 2026Moderate risk

  Diagnostica Stago, Inc. : STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test

  Diagnostica Stago, Inc. is recalling STA Staclot Protein S reagent, catalog number 00746, lot 273074. The reagent shows a positive drift in quality control values within its stated 4-hour onboard stability period, which could affect test results for patients. Consumers should stop using the affected lot and contact Diagnostica Stago for instructions.

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• openFDA · September 9, 2026Moderate risk

  AVID Medical, Inc. : Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit)…

  AVID Medical is recalling Halyard medical convenience kits, including A-P, posterior, aneurysm, spine, cervical, and crani packs. The kits contain Medicom neurological sponges with potentially variable endotoxin levels, posing a risk of fever or inflammatory reactions to patients. Consumers should stop using the recalled kits and contact AVID Medical for return or replacement instructions.

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• openFDA · September 9, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A

  Medline Industries, LP is recalling two Convenience Kits: Blood Culture Tray Pediatric (DYNDH1193) and Blood Culture Kit 2 w/Connect (DYNDH1487A). The kits contain applicators with a potential sterility breach due to wrinkles in the paper lidding, exposing patients and users to microbial contamination. Consumers should check whether their kit matches the recalled model numbers.

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• openFDA · September 9, 2026Moderate risk

  Mylan Pharmaceuticals Inc : Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC,…

  Mylan Pharmaceuticals Inc is recalling Mycophenolate Mofetil for injection, USP, 500 mg/vial, sold under the Mylan Institutional LLC label. The product fails dissolution specifications, which may affect patients receiving the injection. Consumers should contact their healthcare provider or pharmacy for guidance.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter…

  Baxter Healthcare Corporation is recalling Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL, in single-dose GALAXY containers. The product may be unsafe due to manufacturing quality deviations, exposing patients who receive the injection to potential harm. Consumers should stop using the recalled product and contact their healthcare provider or pharmacy for guidance.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter…

  Baxter Healthcare Corporation is recalling Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL, in GALAXY Single-Dose Containers. The product may be unsafe due to manufacturing quality deviations, posing a risk to patients who receive it. Consumers should stop using the recalled product and contact their healthcare provider or pharmacy for guidance.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by:…

  Baxter Healthcare Corporation is recalling Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL, in GALAXY 50 mL single-dose containers. The product may not be sterile due to manufacturing quality deviations, posing a risk of infection to patients receiving this injectable drug. Consumers should stop using the recalled lot and contact their healthcare provider or pharmacy for guidance.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare…

  Baxter Healthcare Corporation is recalling Vasopressin in 0.9% Sodium Chloride Injection, 40 units per 100 mL, 100mL single-dose containers. The product has manufacturing quality deviations, exposing patients to potential risk from the injection. Consumers should contact their healthcare provider or pharmacy for instructions on returning or replacing the product.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare…

  Baxter Healthcare Corporation is recalling Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL in GALAXY single-dose containers. The recall is due to current good manufacturing practice deviations, affecting patients nationwide, in Puerto Rico, and Chile. Consumers should contact their healthcare provider or pharmacy for instructions.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc.,…

  Baxter Healthcare Corporation is recalling Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY containers. The recall is due to manufacturing deviations that may affect product quality, posing a risk to patients who receive this sterile injection. Consumers should stop using the affected product and contact their healthcare provider or pharmacy for instructions.

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• openFDA · September 9, 2026Low risk

  Bionpharma Inc. : Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc.,…

  Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottles. The bottles may contain foreign tablets or capsules, posing a risk to consumers nationwide who have this prescription drug. Consumers should stop using the affected bottles and contact Bionpharma for return or replacement instructions.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC…

  Baxter Healthcare Corporation is recalling MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL. The recall is due to CGMP deviations, meaning the drug may not meet quality standards, posing a risk to patients nationwide, in Puerto Rico, and Chile. Consumers should stop using the recalled product and follow the company's recall instructions.

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• openFDA · September 9, 2026Moderate risk

  Lexia LLC : Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's,…

  Broadway Joe's Pain Cream (3000 mg CBD, 4 oz jar) is affected. The hazard is potential contamination of raw material due to CGMP deviations, exposing consumers who bought the product in Colorado. Consumers should stop using the product and return it to the place of purchase.

  drugs
• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by:…

  Baxter Healthcare Corporation is recalling Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL, in GALAXY 50 mL single-dose containers. The product may be contaminated or otherwise fail quality standards due to manufacturing deviations, posing a risk to patients who receive the injection. Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or guidance.

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• openFDA · September 9, 2026Moderate risk

  Allies Group Inc. : THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed…

  The recall affects THE ONE SPF 50 Invisible Sunscreen Gel, distributed by Allies Group, in 20ml tubes. The product may not provide the SPF 50 protection stated on the label, exposing users to increased risk of sunburn and skin damage. Consumers should stop using the recalled sunscreen and return it to the place of purchase or contact Allies Group for a refund.

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• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter…

  Baxter Healthcare Corporation is recalling Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL, in Galaxy 100 mL single-dose containers. The product may have manufacturing quality deviations, posing a risk to patients who receive this injection. Consumers should stop using the recalled product and contact their healthcare provider for guidance.

  drugs
• openFDA · September 9, 2026Moderate risk

  Allies Group Inc. : THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by…

  The affected product is THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, distributed by Allies Group Inc., in 50ml tubes. The sunscreen may not provide the labeled SPF 50 protection, exposing users to sunburn risk. Consumers should stop using the affected product and return it to the place of purchase.

  drugs
• openFDA · September 9, 2026Moderate risk

  Baxter Healthcare Corporation : Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare…

  Baxter Healthcare Corporation is recalling Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL, in GALAXY 50 mL single-dose containers. The recall is due to manufacturing quality deviations that may affect sterility or potency, posing a risk to patients who receive this injectable drug. Patients and healthcare providers should stop using the recalled product and return it or contact Baxter for instructions.

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Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.