Class II · Moderate risk
Amlodipine and Valsartan Tablets 10 mg/320 mg
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Is Amlodipine recalled?
Yes — there is an active recall. 32 ongoing FDA recalls mention Amlodipine (95 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amlodipine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Amlodipine recalls on record
none so far in 2026; 95 on record, newest first
Class II · Moderate risk
Amlodipine and Valsartan Tablets 5 mg/320 mg
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets 10 mg/160 mg
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets 5 mg/160 mg
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class III · Low risk
Amlodipine Besylate USP 10 mg Tablets
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Class II · Moderate risk
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Class II · Moderate risk
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class III · Low risk
Amlodipine Besylate Tablet
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Class III · Low risk
Amlodipine Besylate Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Amlodipine Besylate Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
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