PlainRecalls

2025 Recalls

6,168 recalls · Page 122 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 5 critical, 42 moderate, and 3 lower-severity recalls. The page references 21 distinct recalling firms operating in 7 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (30), FDA Drug (10), CPSC (5), 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 Low Jan 8, 2025

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, …

AvKARE

FDA Drug Moderate Jan 8, 2025

Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ…

VIONA PHARMACEUTICALS INC

FDA Drug Moderate Jan 8, 2025

Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 5…

AvKARE

FDA Drug Moderate Jan 8, 2025

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Jan 8, 2025

ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ…

Hikma Injectables USA Inc

FDA Drug Critical Jan 8, 2025

FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

GNMart LLC

FDA Drug Moderate Jan 8, 2025

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 630…

Hikma Injectables USA Inc

FDA Drug Low Jan 8, 2025

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-…

SOMERSET THERAPEUTICS LLC

FDA Drug Moderate Jan 8, 2025

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, N…

VIONA PHARMACEUTICALS INC

FDA Drug Low Jan 8, 2025

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, ww…

AvKARE

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANT…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

See DocMan

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2…

Medtronic Neuromodulation

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR H…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237

Carwild Corporation

FDA Devices Moderate Jan 8, 2025

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, …

Medtronic Neuromodulation

FDA Devices Moderate Jan 8, 2025

SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid fro…

Med Michigan Holding Llc

FDA Devices Moderate Jan 8, 2025

AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

Angiodynamics, Inc.

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206

Carwild Corporation

FDA Devices Moderate Jan 8, 2025

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

Baxter Healthcare Corporation

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fl…

Carwild Corporation

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

Baxter Healthcare Corporation

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT E…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNC…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS7801…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

See DocMan

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2…

Medtronic Neuromodulation

FDA Devices Moderate Jan 8, 2025

See DocMan

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 8, 2025

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN …

Medtronic Neuromodulation

FDA Devices Moderate Jan 8, 2025

3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodont…

3M Unitek Corporation

FDA Devices Moderate Jan 8, 2025

Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS …

MEDLINE INDUSTRIES, LP - Northfield

CPSC Moderate Jan 8, 2025

Multi-Purpose Children's Helmets Recalled Due to Risk of Head Injury; Violation of Federal Regulations for Bicycle Helmets; Sold Exclusively on Amazo…

CPSC Moderate Jan 8, 2025

SIG SAUER Recalls ROMEO5 Red Dot Firearm Sights Due to Ingestion Hazard; Violations of Reese's Law Federal Safety Regulations for Consumer Products w…

NHTSA Critical Jan 7, 2025

TESLA 2023-2025: BACK OVER PREVENTION:SOFTWARE

TESLA

CPSC Moderate Jan 2, 2025

Euqee Wintergreen Essential Oils Recalled Due to Risk of Poisoning; Violation of the Poison Prevention Packaging Act; Sold Exclusively on Amazon.com …

DingLinWangLuoKeJiGuang ZhouYouXianGongSi, dba DLWL-US, of China

CPSC Moderate Jan 2, 2025

Kawasaki Motors USA Recalls John Deere ZTrak Zero Turn Mowers with Kawasaki Engines Due to Fire and Burn Hazards

Kawasaki Motors Manufacturing Corp. U.S.A. (engine manufacturer), of Maryville, Missouri

CPSC Moderate Jan 2, 2025

Yaomiao Children's Jewelry Sets Recalled Due to Risk of Lead and Cadmium Poisoning; Violations of the Federal Lead Content Ban and Federal Hazardous …

Wuhannuoyunxindianzikejiyouxiangongsi, (dba LordRoads), of China

NHTSA Critical Jan 2, 2025

ASTON MARTIN 2025: BACK OVER PREVENTION:DISPLAY FUNCTION

ASTON MARTIN

FDA Food Moderate Jan 1, 2025

BORSARI Food Company Incorporated; BLOODY MARY MIX ; 32 FL. OZ; INGREDIENTS: Tomato juice, corn syrup, non-fat milk solids, orange juice, lemon juice…

Borsari Food Company Inc

FDA Food Critical Jan 1, 2025

Kirkland Signature ORGANIC EGGS PASTURE-RAISED 24 EGGS, GRADE A LARGE, NET WEIGHT 48OZ (3 LB) 1.36 kg, UPC 0 96619 10680 6, DISTRIBUTED BY: COSTCO WH…

Handsome Brook Farms, LLC

FDA Food Critical Jan 1, 2025

Cucumber Diced Greek Cut (1/8"x1/8"x1"), 360# Drum with poly liner item C0376, 30# Box with poly liner item C0369. Cucumber Diced Regular Cut (1/8"x1…

E-Z SPUDS 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.