The Recall Desk
SevereFDA (Drugs)·D-1119-2019·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.

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, which corresponds to a Severe rating under the rubric for significant health risks.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, in 30-count, 90-count, and 1000-count bottles. The recall involves 173,760 bottles distributed nationwide in the United States and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product at levels above the interim acceptable daily intake level.

Consumers should stop using the recalled medication and contact their healthcare provider for a replacement prescription. The specific lot numbers and expiration dates affected are listed in the official recall notice.

The recalled product

Product
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: To
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
173,760

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 BEF6D038
  • exp 4/30/2020
  • [90-count bottle] Lots BEF6D030
  • BEF6D031
  • Lots BEF6D047
  • BEF6D048
  • BEF6D049
  • BEF6D050
  • BEF6D051
  • exp 7/31/2020
  • Lots BEF6D082
  • BEF6D083
  • BEF6D084
  • BEF6D085
  • BEF6D086
  • BEF6D087
  • exp 10/31/2020
  • Lots 4P04E003

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 →

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