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 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
Brand
Golden State Medical Supply Inc.
Lot Codes / Batch Numbers
GS014054 exp 06/2019, GS016338 exp 12/2019, GS016341 exp 01/2020, GS016342 exp 01/2020, GS016343 exp 01/2020, GS016344 exp 01/2020, GS016345 exp 01/2020, GS016539 exp 01/2020, GS016969 exp 01/2020, GS016973 exp 01/2020, GS017337 exp 01/2020, GS018524 exp 02/2020
Products Sold
GS014054 exp 06/2019, GS016338 exp 12/2019, GS016341 exp 01/2020, GS016342 exp 01/2020, GS016343 exp 01/2020, GS016344 exp 01/2020, GS016345 exp 01/2020, GS016539 exp 01/2020, GS016969 exp 01/2020, GS016973 exp 01/2020, GS017337 exp 01/2020, GS018524 exp 02/2020
Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 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