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

576–600 of 89371

SevereFDA (Drugs)·D-0715-2026·2026-07-29
ROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO Cooling Eye Drops due to a lack of assurance of sterility. The recall affects multiple lots distributed nationwide within the United States.
Product
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0703-2026·2026-07-29
Levothyroxine Sodium Tablets Recalled for Subpotency
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 88 mcg, lot N02310, due to subpotency. The recall is voluntary and affects nationwide distribution in the USA.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0720-2026·2026-07-29
FDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
Rohto-Mentholatum is recalling 972,001 cartons of ROHTO DRY-AID sterile eye drops due to lack of assurance of sterility. The recall affects lots distributed nationwide in the U.S.
Product
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0727-2026·2026-07-29
Naropin Injection Recall Over Particulate Matter Contamination
Fresenius Kabi is recalling 92,600 vials of NAROPIN (ropivacaine hydrochloride) injection, 0.5%, 10/2028, due to the presence of particulate matter, including hair, found in the product.
Product
NAROPIN — NAROPIN (ROPIVACAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2778-2026·2026-07-29
MiniMed Go App Recalled Due to Missed Insulin Alerts
Medtronic is recalling its MiniMed Go app because a software bug can prevent insulin dose alerts during nighttime, potentially leading to missed doses and hyperglycemia.
Product
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-1179-2026·2026-07-29
Brooklyn Roasting Company Pasteurized Cold Brew Concentrate Recalled Due to Botulism Risk
Brooklyn Roasting Works LLC is recalling Brooklyn Roasting Company Pasteurized Cold Brew Concentrate because ambient storage may lead to Clostridium botulinum toxin formation.
Product
Brooklyn Roasting Company Pasteurized Cold Brew Concentrate; 2.5gal; bag in a box distributed between 04/01/2026 and 06/20/2026.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2757-2026·2026-07-29
Boston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage
Boston Scientific is recalling its Faradrive Steerable Sheath devices due to potential hemostatic valve damage during preparation, which may cause air ingress and patient harm.
Product
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2754-2026·2026-07-29
FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk
Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.
Product
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0721-2026·2026-07-29
ROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
The FDA is recalling ROHTO DRY-AID cooling eye drops due to lack of assurance of sterility. The product was distributed nationwide in the United States.
Product
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2785-2026·2026-07-29
Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Contamination
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2786-2026·2026-07-29
Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2768-2026·2026-07-29
Medtronic Neurosurgery Recalls Ventriculostomy Kit Due to High Endotoxin Levels
Medtronic Neurosurgery is recalling Ventriculostomy Kit (REF: 46154) because endotoxin levels may exceed acceptable limits for devices contacting cerebrospinal fluid.
Product
Ventriculostomy Kit, REF: 46154
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-1188-2026·2026-07-29
Wonton Wrappers Recalled Due to Undeclared Wheat and Food Colors
Man Fon, Inc. is recalling wonton wrappers because they lack ingredient labeling and contain undeclared wheat and colors Yellow#5 and Yellow#6.
Product
Wonton Wrappers packed into clear flexible plastic bag and sold as 40 units (16oz bags)/case. Wonton Wrappers packed into "Wonton Noodles Net Wt. 5 LBS" plastic bags and sold as 10 units (4-lb bags)/case. Neither product has ingredient labeling information.
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0722-2026·2026-07-29
Rohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling certain lots of Rohto Cooling Eye Drops because the company cannot assure the sterility of the product.
Product
ROHTO — ROHTO (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0728-2026·2026-07-29
Xylocaine Injection Recall Due to Hair Contamination
Fresenius Kabi is recalling 93,250 vials of Xylocaine (lidocaine HCl) injection due to the presence of particulate matter, specifically hair found in the product.
Product
XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2781-2026·2026-07-29
Medline Urology Robotic Procedure Packs Recalled Due to Catheter Surface Contamination
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0711-2026·2026-07-29
LEVOTHYROXINE SODIUM Tablets Recalled Due to Subpotent Drug Content
Major Pharmaceuticals is recalling LEVOTHYROXINE SODIUM 150 mcg tablets because some batches contain less active ingredient than labeled, potentially reducing thyroid hormone effectiveness.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2780-2026·2026-07-29
Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2767-2026·2026-07-29
3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements
PIE Medical Imaging B.V. is recalling 3mensio Workstation (Vascular Fenestrated) software because it may provide inaccurate cardiovascular measurements under specific conditions.
Product
3mensio Workstation (Vascular Fenestrated) software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2779-2026·2026-07-29
Medline Bard Silastic Foley Catheter Kits Recalled Due to Surface Contamination
Medline is recalling 980 Bard Silastic Foley Catheter kits due to increased raw material on the catheter surface that may be harmful.
Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0710-2026·2026-07-29
Levothyroxine Sodium Tablets Recalled Due to Subpotent Drug Concerns
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (125 mcg) because the medication may be subpotent.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0716-2026·2026-07-29
Rohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Max Strength because there is a lack of assurance regarding the product's sterility.
Product
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0701-2026·2026-07-29
Levothyroxine Sodium Tablets Recalled for Subpotency by Major Pharmaceuticals
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (50 mcg) from lot N02200 due to subpotency, meaning the tablets may contain less active ingredient than labeled. Products were distributed nationwide in the USA.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0726-2026·2026-07-29
Lidocaine Injection Recall Due to Hair Contamination
Fresenius Kabi is recalling lidocaine injection vials after hair was found in the product. The recall affects 181,225 vials distributed nationwide.
Product
LIDOCAINE — LIDOCAINE (LIDOCAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2788-2026·2026-07-29
Medline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
Medline Industries, LP is recalling specific Medline medical convenience kits because they may contain BD PurPrep 26 mL contaminated with low levels of Bacillus species.
Product
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
Category
Medical Device
Distribution
10 states

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576–600 of 89371