Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)
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 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
Brand
Golden State Medical Supply Inc.
Lot Codes / Batch Numbers
GS015172 exp 06/2019 GS017634 02/2020, GS017653 exp 02/2020, GS017980 exp 02/2020, GS017276 exp 02/2020, GS017045 exp 02/2020, GS016726 exp 02/2020
Products Sold
GS015172 exp 06/2019 GS017634 02/2020, GS017653 exp 02/2020, GS017980 exp 02/2020, GS017276 exp 02/2020, GS017045 exp 02/2020,GS016726 exp 02/2020,
Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated due to CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable da. 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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
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
IL, MI, MN, PA, TN, TX
Page updated: Jan 7, 2026