The Recall Desk
SevereFDA (Drugs)·D-1267-2019·Announced 2019-05-08

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 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 agency classification is FDA Class II, and the presence of a nitrosamine impurity (NMBA) above acceptable levels is a significant safety hazard that fits the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, in 30-count, 90-count, and 1000-count bottles. The recall involves 331,764 bottles distributed nationwide in the USA and Puerto Rico. The specific lots and expiration dates are listed in the structured product information.

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 who have these specific bottles should stop using the medication and contact their healthcare provider for a replacement or alternative treatment. The product is prescription-only, so patients should consult their prescriber before discontinuing or switching medications.

The recalled product

Product
Losartan Potassium and 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
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
331,764

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 BP02C051
  • exp 10/31/2019
  • Lot BP02D005
  • exp 12/31/2019
  • Lot BEF7D047
  • exp 11/30/2020
  • [90-count bottle] Lot BP02C050
  • Lots BP02D006
  • BP02D007
  • Lot BP02D012
  • exp 1/31/2020
  • Lot BEF7D003
  • exp 3/31/2020
  • Lots BEF7D026
  • BEF7D027
  • BEF7D028
  • exp 8/31/2020
  • Lots BEF7D045

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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