Losartan Potassium Tablets (Strides) – CGMP 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, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08
Brand
Strides Pharma Inc.
Lot Codes / Batch Numbers
NDC 64380-933-05 Lot 7901007A, Exp Date Jun-22, Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22, Lots 7901246A & 7901247A, Exp Date Oct-22, Lot 7901343A, Exp Date Dec-22. NDC 64380-933-08 Lot 7901006A, Exp Date Jun-22, Lot 7901145A & 7901180A, Exp Date Sep-22, Lot 7901181A, Exp Date Oct-22.
Products Sold
NDC 64380-933-05 Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 7901247A, Exp Date Oct-22; Lot 7901343A, Exp Date Dec-22. NDC 64380-933-08 Lot 7901006A, Exp Date Jun-22; Lot 7901145A & 7901180A, Exp Date Sep-22; Lot 7901181A, Exp Date Oct-22.
Strides Pharma Inc. is recalling Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limi 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