Medicines & devicesClass II
Zydus Pharmaceuticals (USA) Inc recalls Hydrocortisone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications.
· FDA · Nationwide
Recalls
Safety recalls that rarely make the news, straight from the official U.S. agency records (FDA, USDA, CPSC, NHTSA). Every listing links to its official notice. We only copy what the record says.
Checked Nov 2, 2:59 PM ET · refreshed about every 2.5 hours · RSS · Get recall alerts
FDA drug and medical device recalls.
State filter: shows recalls whose official distribution lists that state, plus nationwide ones. CPSC and NHTSA recalls apply nationwide.
305 recalls for “AI”
Medicines & devicesClass II
Preferred Pharmaceuticals, Inc. recalls Lidocaine Ointment USP
Failed Content Uniformity Specifications
· FDA · Nationwide
Medicines & devicesClass III
SUN PHARMACEUTICAL INDUSTRIES INC recalls 3 products
Failed Impurities/Degradation Specifications
· FDA · Nationwide
Medicines & devicesClass II
Apotex Corp. recalls Paroxetine Extended-Release Tablets
Failed dissolution specifications.
· FDA · Nationwide
Medicines & devicesClass II
Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution
Failed Impurities/Degradation Specifications
· FDA · Nationwide
Medicines & devicesNot Yet Classified
Aurobindo Pharma USA Inc recalls amazon
Discoloration: consumer complaints received for discolored tablets
· FDA · Nationwide
Medicines & devicesClass II
Ajanta Pharma USA Inc recalls Ranolazine Extended-Release Tablets
Failed Dissolution Specifications: below specification
· FDA · Nationwide
Medicines & devicesClass II
Howmedica Osteonics Corp. recalls 4 products
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual mo
· FDA
Medicines & devicesClass II
Cook Incorporated recalls Williams Cystoscopic Injection Needles
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this
· FDA · FL, IL, NM, TX, WA
Medicines & devicesClass II
Baxter Healthcare Corporation recalls Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product
Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients a
· FDA · Nationwide
Medicines & devicesClass II
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
· FDA · Nationwide
Medicines & devicesClass II
K.C. Pharmaceuticals, Inc. recalls 8 products
Lack of Assurance of Sterility
· FDA · Nationwide
Medicines & devicesClass II
Amneal Pharmaceuticals, LLC recalls Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
· FDA · Nationwide
Medicines & devicesClass II
Ethicon, LLC recalls PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used,
· FDA · Nationwide
Medicines & devicesClass II
Healthmark Industries Co., Inc. recalls Vinyl Instrument Guards
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
· FDA · Nationwide
Medicines & devicesClass II
Inventia Healthcare Limited recalls Chlorthalidone Tablets
Failed Dissolution Specifications
· FDA · Nationwide
Medicines & devicesClass II
OurPharma LLC recalls fentaNYL Citrate
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
· FDA · Nationwide
Medicines & devicesClass I
Instrumentation Laboratory recalls 2 products
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
· FDA · Nationwide
Medicines & devicesClass II
W L Gore & Associates, Inc. recalls Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis
The potential for the devices to be mislabeled with the incorrect length.
· FDA · Nationwide
Medicines & devicesClass I
Draeger, Inc. recalls VentStar Resus Neo
Potential cracks in the hose, which could lead to leakage or the hose falling off.
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 12 products
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
· FDA · Nationwide
Medicines & devicesClass II
TerSera Therapeutics LLC recalls Zoladex (goserelin) implant
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
· FDA · Nationwide
Medicines & devicesClass II
SUN PHARMA /TARO recalls Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
· FDA · Nationwide
Medicines & devicesClass III
Supernus Pharmaceuticals, Inc. recalls Trokendi XR
Failed dissolution specifications.
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 6 products
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
· FDA · Nationwide
Medicines & devicesClass II
Steris Corporation recalls 6 products
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator
· FDA · Nationwide
Medicines & devicesClass III
Mindray DS USA, Inc. recalls 8 products
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
· FDA · Nationwide
Medicines & devicesClass II
Intellijoint Surgical, Inc. recalls Intellijoint Navigation System: Workstation G2 Configured
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat
· FDA · Nationwide
Medicines & devicesClass II
LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
· FDA · Nationwide
Medicines & devicesClass II
Philips North America recalls 12 products
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction w
· FDA · Nationwide
Recall data comes from official U.S. government sources: openFDA (food, drugs, devices), USDA FSIS (meat, poultry, egg products), CPSC (consumer and children’s products) and NHTSA (vehicles, equipment, car seats). openFDA notes its data should not be relied on for medical decisions. Always confirm with the official notice. Check your vehicle by VIN at nhtsa.gov/recalls.