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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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May 11, 20225 recalls

RecallClassStatus
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · Lupin Pharmaceuticals Inc. · 657,336 bottlesClass IITerminatedLosartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · Lupin Pharmaceuticals Inc. · 1,247,067 bottlesClass IITerminatedLosartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · Macleods Pharma Usa Inc · 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tabletsClass IITerminatedLosartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · Macleods Pharma Usa Inc · 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tabletsClass IITerminatedLosartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · Macleods Pharma Usa Inc · 12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tabletsClass IITerminated

January 19, 20221 recall

December 1, 20211 recall

November 24, 20211 recall

November 10, 20212 recalls

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.