Losartan Potassium Tablets (Torrent Pharma) – 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 / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
Brand
Torrent Pharma Inc.
Lot Codes / Batch Numbers
Count, lots, expiry: [30-count bottle] Lot BEF7D017, exp 6/30/2020 [90-count bottle] Lots BEF7D010, BEF7D011, exp 4/30/2020, Lot BEF7D018, exp 6/30/2020, Lot BEF7D009, exp 4/30/2020, Lots 4P02E002, 4P02E003, 4P02E004, exp 1/31/2021, [1000-count bottle] Lots BEF7D008, BEF7D012, BEF7D013, exp 4/30/2020, Lot BEF7D022, exp 8/31/2020, Lot BEF7D049, exp 11/30/2020, Lots 4P02E005, 4P02E006, exp 1/31/2021
Products Sold
Count, lots, expiry: [30-count bottle] Lot BEF7D017,exp 6/30/2020 [90-count bottle] Lots BEF7D010, BEF7D011, exp 4/30/2020; Lot BEF7D018, exp 6/30/2020; Lot BEF7D009, exp 4/30/2020; Lots 4P02E002, 4P02E003, 4P02E004, exp 1/31/2021; [1000-count bottle] Lots BEF7D008, BEF7D012, BEF7D013, exp 4/30/2020; Lot BEF7D022, exp 8/31/2020; Lot BEF7D049, exp 11/30/2020; Lots 4P02E005, 4P02E006, exp 1/31/2021
Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), due to CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable d. 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.
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