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All product recalls associated with HANA GROUP.
Total Recalls
585
Past Year
22
Class I (Serious)
383
Most Recent
Oct 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Wheat and Soy missing allergens from the product Contains Statement.
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
This recall involves Leatherman Charge Plus and Charge Plus TTi multi-tools. The Charge Plus multi-tools come in black and stainless-steel colors and with a black MOLLE or black nylon sheath. The Charge Plus TTi multi-tools were sold in a stainless-steel color with a black nylon sheath. The name "Leatherman" is etched on the product.
Defective container; blister packaging inadequately sealed.
Defective container; blister packaging inadequately sealed.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Undeclared allergens (soy, milk) and Yellow #5
Products contain elevated levels of Lead (Pb): 6.504 ppm
Products contain elevated levels of Lead (Pb): 3.231 ppm and Arsenic (As): 0.958 ppm;
Products contain elevated levels of Lead (Pb): 3.688 ppm
Products contain elevated levels of Lead (Pb): 88.038 ppm
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Failed Dissolution Specifications.
Product contains elevated levels of lead - 6.50 mg/kg (ppm)
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.