Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent
FDA recalls Torrent's 25mg Losartan Potassium Tablets due to NDEA impurity exceeding safe levels. Stop using if you have the specific lot number.
Stop using this now
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Contact the company & request your remedy
What happened, in plain English
Torrent Pharma recalls 25mg Losartan Potassium Tablets (NDC 13668-113-90) because FDA found harmful impurities. This impurity could cause serious health risks if taken regularly. Read more at govinfonow.com/recall/39298-torrent-losartan-potassium-tablets-25mg-recall-ndea-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39298-torrent-losartan-potassium-tablets-25mg-recall-ndea-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0503-2019
Cite this page
“Torrent Losartan Potassium Tablets 25mg Recall: NDEA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39298-torrent-losartan-potassium-tablets-25mg-recall-ndea-impurity-risk. Based on FDA recall #D-0503-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0503-2019%22&limit=1).
Why it’s dangerous
The tablets contain N-nitrosodimethylamine (NDEA), a known carcinogen. FDA confirmed levels exceed the safe limit for daily use, which could lead to serious health issues over time.
Who’s affected
People with a prescription for this specific tablet product. Those taking blood pressure medication are most at risk.
How to tell if you have this one
Check for the 90-count bottle labeled 'Losartan Potassium Tablets, USP, 25 mg'. Look for lot number 4O49C013 and expiration date 09/2019 on the packaging.
- Brand
Torrent- Category
Drug
All 5 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-0501-2019 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda; Count, lots, expiry: [30-count bottle] Lot BO31C016, exp 04/2019; [90-count bottle] Lot BO31C016, exp 04/2019; [1000-count bottle] Lots 4DK3C004, 4DK3C005, exp 04/2019; Lots 4DU3C040, exp 10/2019; Lots 4DU3E049, 4DU3E050, exp 05/2021 | 83,016 bottles |
| D-0502-2019 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda; Count, lots, expiry: [30-count bottle] Lot 4L67C035, exp 10/2019; [90-count bottle] Lot 4L67C035, 4L67C036 exp 10/2019; [1000-count bottle] Lot 4O50C005, exp 11/2019 | 65,832 bottles |
| D-0503-2019 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda; Count, lots, expiry: [90-count bottle] Lot 4O49C013, exp 09/2019 | 43,416 bottles |
| D-0504-2019 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda; Count, lots, expiry: [90-count bottle] Lot BX35C020, exp 05/2019, Lot BX35C049, exp 08/2019; [1000-count bottle] Lots BX35C022, BX35C023, exp 05/2019 | 18,852 bottles |
| D-0505-2019 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda; Count, lots, expiry: [90-count bottle] Lot BP02C008, exp 03/2019; [1000-count bottle] Lots BEF7D006, exp 03/2020 | 18,780 bottles |
What to do — step by step
Stop Using Now
Immediately stop taking the recalled tablets if you have a prescription for this product.
Questions people ask
Is this product safe to use?
No, the FDA confirmed harmful impurities in this specific batch that could cause serious health risks.
How can I check if I have the recalled product?
Look for the 90-count bottle with lot number 4O49C013 and expiration date 09/2019 on the packaging.
What should I do if I have the recalled product?
Stop using it immediately and contact your doctor for alternative treatment options.
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-0503-2019 — Torrent Torrent Hello, I own a Torrent that is covered by recall D-0503-2019 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-0503-2019 (December 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0503-2019 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.