Losartan Potassium Tablets (PD-Rx Pharmaceuticals) – CGMP Impurity Deviation (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 Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1
Brand
PD-Rx Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lots: D21C18 Exp. 09/30/22, E21A28 Exp. 09/30/22, E21C04 Exp. 09/30/22, E21D59 Exp. 09/30/22, G21B65 Exp. 09/30/22, H21A12 Exp. 09/30/22, H21D42 Exp. 09/30/22, K21D19 Exp. 10/31/22, A22A73 Exp. 10/31/22
Products Sold
Lots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22
PD-Rx Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx P 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