CLASS II ONGOING Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Losartan Potassium / Hydrochlorothiazide Tablets recalled
Torrent Pharma is recalling Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) (, distributed nationwide in the US. The recall was initiated on 28 Feb 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1118-2019
- FDA event ID
- 82585
- Recalling firm
- Torrent Pharma, Basking Ridge, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Feb 2019
- FDA classified
- 10 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 28 Feb 2019 | Recall initiated by company | |
| 10 Apr 2019 | Classified by FDA | +41 days |
| 17 Apr 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) 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
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Is Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) ( recalled?
Yes. Torrent Pharma recalled Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) ( on 28 Feb 2019. The recall is Class II and its status is Ongoing. Recall number D-1118-2019.
Why was it recalled?
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Which lots are affected?
Count, lots, expiry: [30-count bottle] Lot BEF8D058,exp 11/30/2020 [90-count bottle] Lots BEF8D009, BEF8D010, BEF8D011, BEF8D012, BEF8D013, BEF8D007, BEF8D008, exp 3/31/2020; Lots BEF8D023, BEF8D024, BEF8D025, BEF8D020, BEF8D021, BEF8D022, exp 4/30/2020; Lots BEF8D054, BEF8D055, BEF8D056, exp 10/31/2020; Lots BEF8D057, exp 11/30/2020
Where was it sold?
Nationwide USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Losartan potassium / hydrochlorothiazide recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg recalled | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg recalled | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Losartan Potassium / Hydrochlorothiazide Tablets recalled | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Losartan Potassium / Hydrochlorothiazide Tablets recalled | Torrent Pharma | Nitrosamine Impurity | Nationwide |