PlainRecalls

2025 Recalls

6,168 recalls · Page 69 of 124

2025 Recall Year Insight

Federal agencies issued 6,168 product recalls indexed by PlainRecalls in calendar year 2025. That represents about 6.06% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 16.9 recalls per day across the FDA, CPSC, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 124 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2025.

On this page of 50 records, severity classification shows 4 critical, 46 moderate, and 0 lower-severity recalls. The page references 23 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (32), FDA Drug (18), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2025 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Jul 2, 2025

Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: …

Apotex Corp.

FDA Drug Moderate Jul 2, 2025

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC…

Fresenius Medical Care Holdings, Inc.

FDA Drug Moderate Jul 2, 2025

Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Cor…

Apotex Corp.

FDA Drug Moderate Jul 2, 2025

Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204,…

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, AD…

Advanced Pharmaceutical Technology, Inc.

FDA Drug Moderate Jul 2, 2025

Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made…

Pfizer Inc.

FDA Drug Moderate Jul 2, 2025

LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalam…

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syrin…

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada,…

Apotex Corp.

FDA Drug Moderate Jul 2, 2025

Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

FDA Drug Moderate Jul 2, 2025

0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Beth…

B BRAUN MEDICAL INC

FDA Devices Moderate Jul 2, 2025

REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

GE Medical Systems China Co., Ltd.

FDA Devices Moderate Jul 2, 2025

Spectral CT. Computed tomography X-ray system.

Philips North America Llc

FDA Devices Moderate Jul 2, 2025

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Pro…

Encore Medical, LP

FDA Devices Moderate Jul 2, 2025

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Pro…

Encore Medical, LP

FDA Devices Moderate Jul 2, 2025

REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).

Becton Dickinson & Co.

FDA Devices Moderate Jul 2, 2025

Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 2, 2025

REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 2, 2025

REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

Limacorporate S.p.A

FDA Devices Moderate Jul 2, 2025

Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calciu…

RECORDATI RARE DISEASES INC.

FDA Devices Moderate Jul 2, 2025

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Pro…

Encore Medical, LP

FDA Devices Moderate Jul 2, 2025

Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

Jewel Precision Sheet Metal & Machining Co, Inc.

FDA Devices Critical Jul 2, 2025

Extended Tip Applicator, 15 CM, Box of 5.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Jul 2, 2025

REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Critical Jul 2, 2025

Extended Tip Applicator, 8CM, Box of 5.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Jul 2, 2025

REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413;…

Beckman Coulter Inc.

FDA Devices Moderate Jul 2, 2025

Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303]…

CareFusion 303, Inc.

FDA Devices Moderate Jul 2, 2025

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Pro…

Encore Medical, LP

FDA Devices Critical Jul 2, 2025

Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version …

SunMed Holdings, LLC

FDA Devices Moderate Jul 2, 2025

REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.

Jewel Precision Sheet Metal & Machining Co, Inc.

FDA Devices Moderate Jul 2, 2025

Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot…

BIGFOOT BIOMEDICAL

FDA Devices Critical Jul 2, 2025

Extended Tip Applicator 8CM, Box of 1.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Jul 2, 2025

LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circ…

Jolife AB

FDA Devices Moderate Jul 2, 2025

PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile

Limacorporate S.p.A

FDA Devices Moderate Jul 2, 2025

REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOn…

Becton Dickinson Infusion Therapy Systems, Inc.

FDA Devices Moderate Jul 2, 2025

DxI 9000 Access Immunoassay Analyzer C11137

Beckman Coulter, Inc.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2025 with 2024 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2025

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2025 across the FDA, CPSC and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.