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Blood pressure medication recalls

Every Class I, II, and III FDA recall affecting blood pressure medications. Drugs in this category include Lisinopril, Losartan, Amlodipine, Valsartan.

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August 20, 20254 recalls

RecallClassStatus
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable… · Westminster Pharmaceuticals LLC · 16,672 1000-count bottlesClass IIOngoingCarvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above… · Glenmark Pharmaceuticals Inc., USA · 14,976 bottlesClass IIOngoingCarvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current… · Glenmark Pharmaceuticals Inc., USA · 6,432 bottlesClass IIOngoingCarvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above… · Glenmark Pharmaceuticals Inc., USA · 17, 496 bottlesClass IIOngoing

July 9, 20251 recall

June 4, 20254 recalls

RecallClassStatus
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake… · Glenmark Pharmaceuticals Inc., USA · 84,048 bottlesClass IIOngoingCarvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake… · Glenmark Pharmaceuticals Inc., USA · [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottlesClass IIOngoingCarvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake… · Glenmark Pharmaceuticals Inc., USA · [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottlesClass IIOngoingCarvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake… · Glenmark Pharmaceuticals Inc., USA · 18,696 bottlesClass IIOngoing

April 16, 20251 recall

How FDA classifies recalls

Class I: The drug may cause serious health consequences or death. Examples include the wrong drug in a bottle, a drug contaminated with bacteria, or a life-threatening allergen not declared on the label.

Class II: The drug may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote. Examples include a dissolution failure, a labeling error that affects dosing, or a nitrosamine impurity above the daily intake limit.

Class III: Use of the drug is unlikely to cause adverse health consequences, but the product violates FDA regulations. Examples include an incorrect tablet count per bottle, minor labeling issues, or packaging defects.

Definitions sourced from FDA Recall Classifications →

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.