95 FDA recalls mention Amlodipine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amlodipine.
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Failed Dissolution Specifications: low dissolution results
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Reason cGMP deviations
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing…
Reason Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing…
Reason Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Reason Failed Impurities/Degradation Specifications; 18 month long term stability study.
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture…
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture…
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture…
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture…
Reason Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream…
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
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