Losartan/Hydrochlorothiazide Tablet (Torrent Pharma) – Impurity Detection (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 and 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
Brand
Torrent Pharma Inc.
Lot Codes / Batch Numbers
Count, lots, expiry: [30-count bottle] Lot BP02C051, exp 10/31/2019, Lot BP02D005, exp 12/31/2019, Lot BEF7D047, exp 11/30/2020, [90-count bottle] Lot BP02C050, exp 10/31/2019, Lots BP02D006, BP02D007, exp 12/31/2019, Lot BP02D012, exp 1/31/2020, Lot BEF7D003, exp 3/31/2020, Lots BEF7D026, BEF7D027, BEF7D028, exp 8/31/2020, Lots BEF7D045, BEF7D046, exp 11/30/2020, Lot BEF7E005, exp 1/31/2021, [1000-count bottle] Lots BP02C051, BP02C052, exp 10/31/2019, Lot BEF7D005, exp 3/31/2020, Lots BEF7D029, BEF7D030, exp 8/31/2020, Lot BEF7D048, exp 11/30/2020, Lots BEF7E001, BEF7E002, BEF7E003, BEF7E004, exp 12/31/2020
Products Sold
Count, lots, expiry: [30-count bottle] Lot BP02C051, exp 10/31/2019; Lot BP02D005, exp 12/31/2019; Lot BEF7D047, exp 11/30/2020; [90-count bottle] Lot BP02C050, exp 10/31/2019; Lots BP02D006, BP02D007, exp 12/31/2019; Lot BP02D012, exp 1/31/2020; Lot BEF7D003, exp 3/31/2020; Lots BEF7D026, BEF7D027, BEF7D028, exp 8/31/2020; Lots BEF7D045, BEF7D046, exp 11/30/2020; Lot BEF7E005, exp 1/31/2021; [1000-count bottle] Lots BP02C051, BP02C052, exp 10/31/2019; Lot BEF7D005, exp 3/31/2020; Lots BEF7D029, BEF7D030, exp 8/31/2020; Lot BEF7D048, exp 11/30/2020; Lots BEF7E001, BEF7E002, BEF7E003, BEF7E004, exp 12/31/2020
Torrent Pharma Inc. is recalling Losartan Potassium and 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