Losartan Hydrochlorothiazide (Macleods) – Impurity Levels High (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Brand
Macleods Pharma Usa Inc
Lot Codes / Batch Numbers
Lot # BLL2107B, exp. date 05/2023 BLL2101A, exp. date 01/2025 BLL2102A, exp. date 02/2025 BLL2103B, exp. date 02/2023 BLL2104A, exp. date 05/2023
Products Sold
Lot # BLL2107B, exp. date 05/2023 BLL2101A, exp. date 01/2025 BLL2102A, exp. date 02/2025 BLL2103B, exp. date 02/2023 BLL2104A, exp. date 05/2023
Macleods Pharma Usa Inc is recalling Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 333 due to CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026