Recalls of ARBs, ACE inhibitors, beta blockers and other hypertension drugs - the class behind the large valsartan and losartan nitrosamine recalls.
548 recalls in this category, newest first.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason Subpotent Drug
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Reason Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to…
Reason Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to…
Reason Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Reason Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Reason cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Reason cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Reason Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante…
Reason Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Reason Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related…
Reason Failed Stability Specifications
Reason Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Reason 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…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.