Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

7451–7475 of 89527

SevereFDA (Devices)·Z-1505-2025·2025-04-16
Medline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
Medline is recalling multiple medical convenience kits distributed in California that contain defective intubation endotracheal tubes previously recalled by the manufacturer Smiths Medical. The affected kits are used for neonatal and pediatric resuscitation and intubation procedures.
Product
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1457-2025·2025-04-16
Medline Medical Procedure Kits with Aortic Root Cannula Recalled
Medline is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to potential excess material in the male lures on the cannula. The recall affects 468 units distributed across nine US states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Category
Medical Device
Distribution
9 states
SevereFDA (Drugs)·D-0357-2025·2025-04-16
Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure
Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility resulting from bacterial contamination detected during media fill testing. The recall affects 23,960 vials distributed nationwide.
Product
HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0359-2025·2025-04-16
Proactiv Emergency Blemish Relief recalled for benzene contamination
Alchemee LLC is recalling Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%) due to the presence of benzene, a chemical contaminant. The recall affects approximately 38,237 bottles distributed nationwide.
Product
Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0354-2025·2025-04-16
Methocarbamol Injection USP Recalled Due to Sterility Assurance Concerns
Somerset Therapeutics is recalling Methocarbamol Injection USP (1,000 mg/10 mL vials) nationwide due to lack of assurance of sterility following bacterial contamination in media fill testing.
Product
METHOCARBAMOL — METHOCARBAMOL (METHOCARBAMOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0355-2025·2025-04-16
Haloperidol Decanoate Injection Recalled for Sterility Assurance Defect
Somerset Therapeutics is recalling 997 vials of Haloperidol Decanoate Injection 50mg/mL nationwide due to lack of assurance of sterility following bacterial contamination detected in a media fill validation test.
Product
HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1512-2025·2025-04-16
Hippo 072 Aspiration System recalled for distal tip detachment risk
Qapel Medical Inc. is recalling the Hippo 072 Aspiration System and related components because the aspiration catheter distal tip may detach, potentially causing vessel rupture or vasospasm.
Product
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1545-2025·2025-04-16
BD Pyxis automated dispensing cabinets recalled for software dosing bug
CareFusion 303 is recalling BD Pyxis MedBank and MedFlex automated dispensing cabinets due to a software bug that prevents accurate tracking of medication quantities, potentially causing patients to receive more than the intended dose.
Product
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0347-2025·2025-04-16
OTC Acetaminophen and Ibuprofen Tablets Recalled for Manufacturing Quality Deviations
Glenmark Pharmaceuticals is recalling acetaminophen-ibuprofen tablets due to manufacturing quality deviations. No illnesses reported. Distributed nationwide via Amazon and Walmart.
Product
ACETAMINOPHEN, IBUPROFEN — ACETAMINOPHEN, IBUPROFEN (ACETAMINOPHEN, IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0695-2025·2025-04-16
Las Ollas Botana Mix snack recalled for undeclared allergens
Kedake Inc is recalling Las Ollas Botana Mix snack (2lbs bags) due to undeclared sesame, soy, wheat, and food colorings (Yellow No. 5, Yellow No. 6, Red No. 6) that may pose a risk to consumers with allergies.
Product
Las Ollas Botana Mix snack, 2lbs, item #1516, # 1056, UPC# 880342001855
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0310-2025·2025-04-16
Venlafaxine Tablets 75 mg Recalled for Foreign Metal Material
Zydus Pharmaceuticals is recalling Venlafaxine 75 mg tablets due to a complaint of a metal shaving found embedded in a tablet. The recall affects 13,128 bottles distributed nationwide.
Product
VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0343-2025·2025-04-16
FDA Recalls Lacosamide Tablets for Manufacturing Quality Deviations
Glenmark Pharmaceuticals is recalling Lacosamide 150mg tablets nationwide due to manufacturing quality deviations. Consumers should contact their pharmacy or healthcare provider regarding their supply.
Product
LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1544-2025·2025-04-16
DNA Labeling Kit Component Affected by Chromosome Aberration
Agilent's GenetiSure Dx Labeling Kit contains a human reference DNA component with a mosaic aberration that may cause false test results and diagnosis delays in genetic testing.
Product
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1530-2025·2025-04-16
Wayson Hydrocolloid Bandages Recalled Due to Sterility Compromise Risk
Medline Industries is recalling multiple Wayson Hydrocolloid bandage models due to potential compromise of device sterility. The recalled products were distributed nationwide in the US and internationally.
Product
Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1529-2025·2025-04-16
Beckman Coulter DxI 9000 Immunoassay Analyzer Electrical Short Risk
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzer units due to ground screws on PCB boards that may cause electrical shorts, leading to smoke and delayed patient test results.
Product
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1532-2025·2025-04-16
Omnicell IVX Station Reconstitution Transfer Sets Recall
Omnicell is recalling IVX Station Reconstitution Transfer Sets (Model 298921215) that were shipped in an unvalidated packaging configuration and cannot be assured to be sterile. The devices were intended only for engineering use during setup and system calibration, not clinical use.
Product
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. I
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1518-2025·2025-04-16
FilmArra Pneumonia Panel Plus Diagnostic Kit Recalled for Control and Test Failures
BioFire Diagnostics is recalling 29 units of the FilmArra Pneumonia Panel Plus test kit due to control failures and false negative results. Affected units (Lot 0979424) were distributed to France, Italy, Spain, Switzerland, and Israel.
Product
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0700-2025·2025-04-16
Brioche Bread Loaf and Hamburger Buns Recall for Undeclared Allergens and Dyes
Harvey Investments LLC / The Baking Group is recalling brioche bread loaves and hamburger buns due to undeclared soy and milk allergens and Yellow #5 dye. Consumers with allergies or sensitivities should not consume these products.
Product
Brioche Bread Loaf and Hamburger buns packaged in brown box and labeled as follows: 1. Ben E. Keith Co. Dense Brioche Pullman Loaf, 33 oz. 7 Count, Case Wt. 15 lbs. Product Code: 654203. The Bakery Group, 9106 Sovereign Row, Dallas, TX 75247. GTIN: 00038597654203 2. Ben
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1549-2025·2025-04-16
Medline ReNewal ENT Coblator II Suction Device Drip Chamber Disconnection
Medline ReNewal is recalling 224 units of ENT Coblator II PROcise mAx devices because the drip chambers may disconnect from the saline line tubing under tension, creating a potential surgical hazard.
Product
MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0694-2025·2025-04-16
Dr. Praeger's California Veggie Fries Recalled for Undeclared Soy Allergen
Dr. Praeger's California Veggie Fries 8oz is being recalled due to an undeclared soy allergen. The recall affects 8,665 cases distributed to 15 states; consumers with soy allergies should not consume the product.
Product
Dr. Praeger s California Veggie Fries 8oz,
Category
Food
Distribution
15 states
HighFDA (Devices)·Z-1547-2025·2025-04-16
Medline ReNewal Coblator II ENT Device Drip Chamber Disconnection Risk
Medline is recalling 20 units of ReNewal Coblator II ENT devices because drip chambers may disconnect from saline tubing under tension, potentially disrupting fluid delivery during procedures.
Product
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1546-2025·2025-04-16
Medline ReNewal Coblator II Evac 70 Xtra Plasma Wand Disconnection Risk
Medline Industries is recalling 738 units of the ReNewal Coblator II Evac 70 Xtra Plasma Wand due to risk that drip chambers may disconnect from the saline line tubing under tension.
Product
MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1537-2025·2025-04-16
Stryker Blueprint Mixed Reality Instrument Check Block Recall
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Instrument Check Block (Catalog Number MRUE203) due to an elevated complaint rate involving software and instrumentation malfunctions that prevent the system from functioning as intended.
Product
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Category
Medical Device
Distribution
7 states
HighFDA (Food)·F-0698-2025·2025-04-16
MTN OPS MULTI-V Men's Daily Multivitamin dietary supplement recall undeclared soy
MTN OPS, LLC is recalling MTN OPS MULTI-V Men's Daily Multivitamin dietary supplement (60 capsule bottles) because they contain undeclared soy flour, which poses a risk to consumers with soy allergies.
Product
MTN OPS MULTI-V Men's Daily Multivitamin dietary supplement, 60 Capsule Bottle (30 Serving). Manufactured exclusively for MTN OPS, LLC, 251 S Mountain Rd., Fruit Heights, UT. UPC 8 40359 40458 2
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1548-2025·2025-04-16
Medline ReNewal ENT Coblator II PROcise XP Wand recalled
Medline has recalled 315 units of the ReNewal ENT Coblator II PROcise XP Wand nationwide because the drip chamber may disconnect from the saline line tubing under tension.
Product
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Category
Medical Device
Distribution
Distributed nationwide

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7451–7475 of 89527