Torrent Pharma Inc. recalls Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle,
FDA-confirmed impurity in Torrent Losartan Potassium Tablets may exceed safe levels. Recalled 90-count and 1000-count bottles with specific lot numbers. Stop using immediately if you have these products.
Recall notice
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Contact the company & request your remedy
What happened, in plain English
Torrent Pharma recalls 100mg Losartan Potassium Tablets due to FDA-confirmed impurities that could exceed safe levels. This affects specific lot numbers of 90-count and 1000-count bottles sold between 2019 and 2021. People taking this medication should check their product details and contact the manufacturer if unsure. Read more at govinfonow.com/recall/38898-torrent-losartan-tablets-recall-impurity-risk-in-100mg-dose.
Source Summary by GovInfoNow · govinfonow.com/recall/38898-torrent-losartan-tablets-recall-impurity-risk-in-100mg-dose · Updated October 5, 2026 · FDA enforcement record: FDA #D-1266-2019
Cite this page
“Torrent Losartan Tablets Recall: Impurity Risk in 100mg Dose.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38898-torrent-losartan-tablets-recall-impurity-risk-in-100mg-dose. Based on FDA recall #D-1266-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1266-2019%22&limit=1).
Why it’s dangerous
The FDA found an impurity called N-Methylnitrosobutyric acid (NMBA) in the tablets that may exceed safe levels when consumed. This impurity could potentially cause health issues if taken in amounts above the acceptable daily intake.
Who’s affected
People who have the recalled 90-count or 1000-count Losartan tablets with specific lot numbers from 2019-2021 are affected. Those taking blood pressure medication are most at risk.
How to tell if you have this one
Check for the product name 'Losartan Potassium Tablets, USP, 100 mg' with lot numbers listed in the recall: 4DU3E016, 4DU3C012, 4DU3C015-017, 4DU3C031, 4DU3D007-008, 4DU3E017, 4DU3E019.
- Brand
Torrent- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide USA and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1264-2019 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India; Count, lots, expiry: [90-count bottle] Lot BDK1C003, exp 07/31/2019; [1000-count bottle] Lot BDK1C002, exp 07/31/2019; Lots 4DU1D004, 4DU1D005, 4DU1D006, exp 12/31/2019 | 28,464 bottles |
| D-1265-2019 | Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India; Count, lots, expiry: [90-count bottle] Lots 4DU2D005, 4DU2D006, exp 12/31/2019; Lots 4DU2D026, 4DU2D027, 4DU2D029, exp 3/31/2020; Lot 4DU2E007, exp 12/31/2020; [1000-count bottle] Lot 4DU2D017, exp 2/29/2020, Lots 4DU2D025, 4DU2D028, exp 3/31/2020; Lots 4DU2D040, 4DU2D041, 4DU2D042, 4DU2D045, 4DU2D046, 4DU2D047, 4DU2D048, exp 8/31/2020; Lot BDK2E001, exp 12/31/2020; Lots 4DU2E042, 4DU2E044, exp 2/28/2021; Lots BDK2E012, BDK2E013, exp 8/31/2021 | 164,424 bottles |
| D-1266-2019 | Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India; Count, lots, expiry: [90-count bottle] Lot 4DU3E016, exp 01/31/2021; [1000-count bottle] Lot 4DU3C012, exp 7/31/2019; Lots 4DU3C015, 4DU3C016, 4DU3C017, exp 8/31/2019; Lot 4DU3C031, exp 9/30/2019; Lots 4DU3D007, 4DU3D008, exp 1/31/2020; Lot 4DU3E017, exp 1/31/2021; Lot 4DU3E019, exp 2/28/2021 | 65,184 bottles |
| D-1267-2019 | 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; 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 | 331,764 bottles |
| D-1268-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India; Count, lots, expiry: [90-count bottle] Lot BX35D024, exp 1/31/2020; BEF8D060, BEF8D061, BEF8D062, BEF8D063, BEF8D064, exp 11/30/2020; [1000-count bottle] Lot BEF8D059, exp 11/30/2020; Lots BEF8E004, BEF8E005, exp 1/31/2021 | 54,084 bottles |
| D-1269-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India; Count, lots, expiry: [30-count bottle] Lot BEF6D054, exp 8/31/2020; [90-count bottle] Lot BP04C092, exp 10/31/2019; Lots BP04D012, BP04D013, exp 12/31/2019; Lots BEF6D012, BEF6D013, exp 3/31/2020; Lots BEF6D060, BEF6D061, BEF6D063, exp 9/30/2020; Lots BEF6D076, BEF6D077, BEF6D078, BEF6D079, exp 10/31/2020; Lots BEF6D100, BEF6D101, BEF6D102, exp 11/30/2020; Lots BEF6E001, BEF6E002, BEF6E003, BEF6E004, BEF6E008, BEF6E009, BEF6E010, BEF6E011, BEF6E012, exp 12/31/2020 | 239,016 bottles |
What to do — step by step
Check Product Details
Look for the product name and specific lot numbers listed in the recall to confirm if your tablets are affected.
Questions people ask
Is this impurity dangerous?
The FDA confirmed the presence of an impurity that may exceed safe levels, but the exact health risk is not specified in the recall notice.
How do I know if my tablets are recalled?
Check the lot number on your bottle against the list provided: 4DU3E016, 4DU3C012, 4DU3C015-017, 4DU3C031, 4DU3D007-008, 4DU3E017, 4DU3E019.
What should I do if I have the recalled tablets?
The recall notice does not specify a remedy, so contact Torrent Pharmaceuticals for further instructions.
Contact Torrent
We’ve drafted a message you can send Torrent to request your refund or repair — edit it as you like.
Subject: Recall D-1266-2019 — Torrent Torrent Hello, I own a Torrent that is covered by recall D-1266-2019 from Torrent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1266-2019 (April 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1266-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.