The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1117-2019·Announced 2019-04-17

Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, and the presence of a nitrosamine impurity (NMBA) above acceptable levels constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury/health risk reports.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, in 30-count, 90-count, and 1000-count bottles. The product is prescription-only and was distributed nationwide in the United States and Puerto Rico.

The recall was initiated because FDA laboratory testing confirmed the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), in the finished product at levels above the interim acceptable daily intake. This finding represents a deviation from Current Good Manufacturing Practices (CGMP).

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider for a replacement or alternative treatment. The specific lot numbers and expiration dates for the recalled products are listed in the official FDA recall notice.

The recalled product

Product
Losartan Potassium / 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. For…
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard

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 (20)

  • Count
  • lots
  • expiry: [30-count bottle] Lot BEF7D017
  • exp 6/30/2020 [90-count bottle] Lots BEF7D010
  • BEF7D011
  • exp 4/30/2020
  • Lot BEF7D018
  • exp 6/30/2020
  • Lot BEF7D009
  • Lots 4P02E002
  • 4P02E003
  • 4P02E004
  • exp 1/31/2021
  • [1000-count bottle] Lots BEF7D008
  • BEF7D012
  • BEF7D013
  • Lot BEF7D022
  • exp 8/31/2020
  • Lot BEF7D049
  • exp 11/30/2020

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 6 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 6 products in this recall →

Related recalls

Same manufacturer · Torrent Pharma Inc.

See all →

Same hazard · impurity

See all →

Similar recalls