Losartan Pot/HCTZ 100/25mg (Direct Rx) - Impurity Levels (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 Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Brand
Direct Rx
Lot Codes / Batch Numbers
Lots: 08NO2102 Exp. 1/31/25, 17NO2118 Exp. 1/31/25, 18NO2123 Exp. 1/31/25, 25OC2114 Exp. 1/31/25, 22NO2105 Exp. 1/31/25
Products Sold
Lots: 08NO2102 Exp. 1/31/25; 17NO2118 Exp. 1/31/25; 18NO2123 Exp. 1/31/25; 25OC2114 Exp. 1/31/25; 22NO2105 Exp. 1/31/25
Direct Rx is recalling Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonvi 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 noticeDistribution
As reported by FDA
FL
Page updated: Jan 7, 2026