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All product recalls associated with AvKARE.
Total Recalls
20
Past Year
9
Class I (Serious)
0
Most Recent
Sep 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.
Failed Content Uniformity Specifications
Presence of a foreign substance.
Presence of a foreign substance.
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Failed Dissolution Specifications
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Out of Specification for Dissolution
LABELING: LABEL MIX-UP
LABELING: LABEL MIX-UP
Failed Dissolution Specifications
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Labeling: Label Mix-Up
Labeling: Label Mix-Up
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.