PlainRecalls

2025 Recalls

5,015 recalls · Page 21 of 101

2025 Recall Year Insight

Federal agencies issued 5,015 product recalls indexed by PlainRecalls in calendar year 2025. That represents about 5.97% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 13.7 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 101 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 0 critical, 48 moderate, and 2 lower-severity recalls. The page references 21 distinct recalling firms operating in 4 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (38), FDA Drug (12), 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Oct 29, 2025

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sanga…

Graviti Pharmaceuticals Private Limited

FDA Drug Moderate Oct 29, 2025

Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: …

Lannett Company Inc.

FDA Drug Moderate Oct 29, 2025

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46…

The Harvard Drug Group LLC

FDA Drug Low Oct 29, 2025

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceut…

JB Chemicals and Pharmaceuticals Ltd

FDA Drug Moderate Oct 29, 2025

Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye …

ibspot

FDA Drug Moderate Oct 29, 2025

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810…

USV Private Limited

FDA Drug Moderate Oct 29, 2025

Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufa…

Medline Industries, LP

FDA Drug Moderate Oct 29, 2025

Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN…

The Harvard Drug Group LLC

FDA Drug Low Oct 29, 2025

Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceut…

JB Chemicals and Pharmaceuticals Ltd

FDA Drug Moderate Oct 29, 2025

ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25

Church & Dwight Co., Inc.

FDA Drug Moderate Oct 29, 2025

Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceut…

Aspiro Pharma Limited

FDA Drug Moderate Oct 29, 2025

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company,…

Bristol-Myers Squibb Company

FDA Devices Moderate Oct 29, 2025

Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

Medline Industries, LP

FDA Devices Moderate Oct 29, 2025

MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch…

Baxter Healthcare Corporation

FDA Devices Moderate Oct 29, 2025

Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 …

Cardinal Health 200, LLC

FDA Devices Moderate Oct 29, 2025

Model Number 40KWFXPLUS.004, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

UIH Technologies LLC

FDA Devices Moderate Oct 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

UIH Technologies LLC

FDA Devices Moderate Oct 29, 2025

Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube,…

Cardinal Health 200, LLC

FDA Devices Moderate Oct 29, 2025

Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, O…

CPM Medical Consultants, LLC.

FDA Devices Moderate Oct 29, 2025

t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexc…

Tandem Diabetes Care, Inc.

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Oct 29, 2025

Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

SM_40HF_B_D_VIR3, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

SM_40HF_BDC3, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump…

Cardinal Health 200, LLC

FDA Devices Moderate Oct 29, 2025

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray t…

Wipro GE Healthcare Private Ltd.

FDA Devices Moderate Oct 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

UIH Technologies LLC

FDA Devices Moderate Oct 29, 2025

SHIMADZU RF.004, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

UIH Technologies LLC

FDA Devices Moderate Oct 29, 2025

Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

UIH Technologies LLC

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number 40KW-FX.899, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly…

Theken Companies LLC

FDA Devices Moderate Oct 29, 2025

BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUT…

Becton Dickinson & Co.

FDA Devices Moderate Oct 29, 2025

Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

SM_40HF_B_D_VIR3.004, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number 40KWFXPLUS.889, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2025