2,090 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.
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CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Unapproved Drug Claims and Misbranded.
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Enoxaparin Sodium Injection recall active as of 2025. Cardinal Health and Sandoz Inc. distributed the product in Kansas. Bags labeled 80 mg/0.8 mL contained 30 mg/0.3 mL doses. Health authorities urge immediate stop-use and guidance from providers.
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Lack of Assurance of Sterility.
AVID Medical recalls 228 CPT BASIC IR PACKs sold nationwide, including Florida, due to open header bag seals that may compromise sterility. The recall is active as of September 17, 2025. Consumers should stop use and follow manufacturer instructions.
AVID Medical recalled 57 JACK421-04 ENT PACK convenience kits nationwide in Florida. The open header bag seals could compromise sterility. Consumers should stop using the device and follow manufacturer instructions for recall resolution.
Lack of Assurance of Sterility.
B. Braun Medical Inc. recalls 23,100 0.9% Sodium Chloride Injection L 8000 containers nationwide. The recall cites lack of assurance of sterility and potential fluid leakage at a weld site. Stop using immediately and consult a healthcare provider.
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
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