The Recall Desk
SevereFDA (Drugs)·D-0504-2019·Announced 2019-02-27

Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA labs found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as exposure to NDEA, a probable human carcinogen) are categorized as Severe (Score 4), as they are not Class I (Critical) but involve significant health risks.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg. The recall involves 90-count and 1000-count bottles manufactured by Torrent Pharmaceuticals LTD. The affected products are prescription-only medications.

The recall was initiated because FDA laboratory testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The levels of NDEA were found to be above the interim acceptable daily intake level of 0.083 parts per million. This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The affected lots include Lot BX35C020 (exp 05/2019) and Lot BX35C049 (exp 08/2019) for the 90-count bottles, and Lots BX35C022 and BX35C023 (exp 05/2019) for the 1000-count bottles. A total of 18,852 bottles were distributed nationwide in the USA and Puerto Rico. Consumers should check their medication for these specific lot numbers and expiration dates. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
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
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
18,852

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Count
  • lots
  • expiry: [90-count bottle] Lot BX35C020
  • exp 05/2019
  • Lot BX35C049
  • exp 08/2019
  • [1000-count bottle] Lots BX35C022
  • BX35C023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Torrent Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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