Lidolog Kit (Lidocaine HCL Injection, USP, 2%) by Enovachem Pharmaceuticals
The product label wrap covers the barcode, preventing proper scanning during dispensing. This could lead to…
Zen Principle Moringa Leaf Powder Capsules by Zen Principle
The product may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal…
Presource ®Kits containing Teleflex Pilling® Wecksorb Neurosponge by Cardinal Health 200, LLC (also trading as Cardinal Health) / Teleflex Pilling
The affected Wecksorb Neurosponges may contain out-of-specification or potentially out-of-specification levels of endotoxin. Exposure during surgical…
Leoni Plus by Lowenstein Medical Se & Co. Kg
An electronic component inside the Leoni Plus device may overheat internally. This could lead to device…
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton by BD (Becton, Dickinson and Company) / CareFusion
Affected applicators may have an open or incomplete seal on the packaging, which could compromise the…
Apo-Tiotropium 18 mcg Capsules by Apotex Inc.
The particle size in the affected lots did not meet product specifications, which could affect how…
Fexofenadine Hydrochloride Tablets, USP 180 mg by Ohm Laboratories Inc (Sun Pharmaceutical Industries Inc)
The affected tablets failed impurities and degradation specifications, meaning the product may not meet required purity…
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g by Padagis
Testing revealed the cream is subpotent, meaning it may contain less active ingredient than required. This…
TAVNEOS (avacopan) capsules, 10 mg by Otsuka Canada Pharmaceutical Inc.
A key clinical trial used to support TAVNEOS's original authorization, the ADVOCATE trial, has significant data…
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial by Hikma / THYMOORGAN PHARMAZIE GmbH
The product was stored at controlled room temperature instead of being refrigerated as required, which may…
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial by Lupin Pharmaceuticals, Inc.
The syringe in the kit failed a Gliding Force functionality test, meaning the plunger may not…
Vista MAX Dietary Supplement, 90 Capsules by Vision of Health
Vista MAX contains undeclared Yellow #5, a color additive not listed on the product label. Consumers…
Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9 by PH Labs
The supplement contains undeclared Yellow #5, a synthetic dye not listed on the label. Consumers with…
Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) by Oribe
The affected shampoo lots may be contaminated with Pluralibacter gergoviae bacteria. While this poses little medical…
Penumbra System RED 68 Reperfusion Catheter by Penumbra Inc.
A manufacturing or performance issue in specific lots of the RED 68 Reperfusion Catheter may cause…
Methylergonovine Maleate Tablets, USP, 0.2 mg by Major Pharmaceuticals
The recalled tablets are subpotent, meaning they may contain insufficient levels of the active ingredient methylergonovine…
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules by Ajanta Pharma
The recalled Fenofibrate Capsules were manufactured under conditions that deviated from FDA current Good Manufacturing Practice…
MED-RX Wound Care Kit by Canadian Hospital Specialties Ltd. (CHS)
The BD Chloraprep applicators used in the MED-RX Wound Care Kit may have compromised sterility due…
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay by Siemens Healthcare Diagnostics Inc.
The assay may produce falsely depressed or falsely elevated hemoglobin A1c results due to intermittent well-to-well…
TNVitamins Ultra Potent Complete Green Superfood Moringa Capsules and Doctor's Pride Complete Green Superfood Ultra Potent Moringa Capsules by TNVitamins and Doctor's Pride
The products may be contaminated with Salmonella, a bacterium that can cause serious and sometimes fatal…
