PlainRecalls

2025 Recalls

6,168 recalls · Page 54 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 7 critical, 43 moderate, and 0 lower-severity recalls. The page references 15 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 (33), FDA Drug (17), 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 Aug 13, 2025

Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refr…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigera…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigera…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: …

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Aug 13, 2025

Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerat…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

Cardinal Health Inc.

FDA Drug Moderate Aug 13, 2025

Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrig…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India,…

Alembic Pharmaceuticals Limited

FDA Drug Moderate Aug 13, 2025

Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Ref…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

Cardinal Health Inc.

FDA Drug Moderate Aug 13, 2025

Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Ref…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refriger…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refr…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refriger…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

Cardinal Health Inc.

FDA Drug Moderate Aug 13, 2025

Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refriger…

AEQUITA PHARMACY

FDA Drug Moderate Aug 13, 2025

Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle,…

Direct Rx

FDA Devices Moderate Aug 13, 2025

UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

Beckman Coulter Inc.

FDA Devices Moderate Aug 13, 2025

GYN ROBOTIC PACK. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

LAP CHOLE PACK. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

Beckman Coulter, Inc.

FDA Devices Moderate Aug 13, 2025

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

Beckman Coulter, Inc.

FDA Devices Moderate Aug 13, 2025

epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Aug 13, 2025

PACK GENERAL ROBOTIC. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

LAVH PACK. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456

Beckman Coulter, Inc.

FDA Devices Moderate Aug 13, 2025

LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Critical Aug 13, 2025

Plum Duo Infusion System, List Number: 400020401

ICU Medical, Inc.

FDA Devices Moderate Aug 13, 2025

BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

Becton, Dickinson and Company, BD Bio Sciences

FDA Devices Moderate Aug 13, 2025

PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Critical Aug 13, 2025

BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U…

Flexicare Medical (Dongguan) Ltd.

FDA Devices Moderate Aug 13, 2025

LAPAROSCOPIC GYN. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Critical Aug 13, 2025

BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U

Flexicare Medical (Dongguan) Ltd.

FDA Devices Critical Aug 13, 2025

BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U

Flexicare Medical (Dongguan) Ltd.

FDA Devices Moderate Aug 13, 2025

LAPAROSCOPIC TRAY. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

ROBOTIC URO/GYN PACK. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Critical Aug 13, 2025

Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U

Flexicare Medical (Dongguan) Ltd.

FDA Devices Moderate Aug 13, 2025

GYN LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

BD Trucount Controls, 30 Test - REF: 340335

Becton, Dickinson and Company, BD Bio Sciences

FDA Devices Moderate Aug 13, 2025

GENERAL LAPAROSCOPY TRAY. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Critical Aug 13, 2025

Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

B BRAUN MEDICAL INC

FDA Devices Moderate Aug 13, 2025

GEN LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

Beckman Coulter, Inc.

FDA Devices Moderate Aug 13, 2025

LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Critical Aug 13, 2025

BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2…

CareFusion 303, Inc.

FDA Devices Moderate Aug 13, 2025

MAJOR THORACOSCOPY BASIN. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

PARTIAL NEPHRECTOMY PACK. Medical convenience kit.

AVID Medical, Inc.

FDA Devices Moderate Aug 13, 2025

DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is indiv…

Nuclein LLC

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 July 2026.