Torrent Pharma Inc. recalls Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for:
FDA recalls Torrent Pharma's 100mg/25mg Losartan/Hydrochlorothiazide tablets due to impurity NMBA above safe levels. Affected lots: NDC 13668-118-90, Lot 4P04D0: stop using immediately.
Stop using this now
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Contact the company & request your remedy
What happened, in plain English
Torrent Pharma is recalling 100mg/25mg Losartan/Hydrochlorothiazide tablets (Rx only) because FDA found an impurity (NMBA) in the product at levels above the safe limit. This could pose a health risk with long-term use, so affected users should stop using the medication immediately. Read more at govinfonow.com/recall/37920-torrent-pharma-losartan-hydrochlorothiazide-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37920-torrent-pharma-losartan-hydrochlorothiazide-tablets-recall-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0124-2020
Cite this page
“Torrent Pharma Losartan/Hydrochlorothiazide Tablets Recall: Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37920-torrent-pharma-losartan-hydrochlorothiazide-tablets-recall-impurity-risk. Based on FDA recall #D-0124-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0124-2020%22&limit=1).
Why it’s dangerous
The FDA confirmed the presence of N-Methylnitrosobutyric acid (NMBA) in the tablets at levels above the acceptable daily intake limit. This impurity could potentially cause health issues with long-term use, though the exact risk level isn't specified in the recall notice.
Who’s affected
Prescription users of the 100mg/25mg Losartan/Hydrochlorothiazide tablets (Rx only) who purchased the product with NDC 13668-118-90 and Lot 4P04D007 are affected. People with hypertension or other conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the NDC code 13668-118-90 and lot number 4P04D007 on the product label. The tablets are prescription-only and come in 90-count bottles.
- Brand
Torrent Pharma- Category
Drug
All 4 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-0121-2020 | Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10; Lot 4DU2E009 | 8,688 bottles |
| D-0122-2020 | Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10; Count, lot, expiry: [90 count] Lot 4DU3E009, exp 12/31/2020; [1000 count] Lot 4DU3D018, exp 02/28/2021 | 39,432 bottles |
| D-0123-2020 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90; Lot BEF7D051 | 17,088 bottles |
| D-0124-2020 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90; Lot 4P04D007 | 8,688 bottles |
What to do — step by step
Stop Using Immediately
Discard the affected tablets as they contain an impurity that could pose health risks with long-term use.
Questions people ask
Is this product safe to use?
No, the FDA found an impurity (NMBA) in the product at levels above the safe limit. Do not use these tablets.
What is the NDC number for the affected product?
The NDC number is 13668-118-90.
How can I check if my tablets are affected?
Check the product label for NDC 13668-118-90 and lot number 4P04D007.
Contact Torrent Pharma
We’ve drafted a message you can send Torrent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0124-2020 — Torrent Pharma Torrent Pharma Hello, I own a Torrent Pharma that is covered by recall D-0124-2020 from Torrent Pharma. 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-0124-2020 (September 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0124-2020 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.