The Recall Desk
SevereFDA (Drugs)·D-1265-2019·Announced 2019-05-08

Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing 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, and the presence of a nitrosamine impurity (NMBA) above acceptable levels constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 50 mg, in 90-count and 1000-count bottles. The recall involves 164,424 bottles 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 above the interim acceptable daily intake level. This finding represents a Current Good Manufacturing Practice (CGMP) deviation.

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

The recalled product

Product
Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) 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
164,424

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: [90-count bottle] Lots 4DU2D005
  • 4DU2D006
  • exp 12/31/2019
  • Lots 4DU2D026
  • 4DU2D027
  • 4DU2D029
  • exp 3/31/2020
  • Lot 4DU2E007
  • exp 12/31/2020
  • [1000-count bottle] Lot 4DU2D017
  • exp 2/29/2020
  • Lots 4DU2D025
  • 4DU2D028
  • Lots 4DU2D040
  • 4DU2D041
  • 4DU2D042
  • 4DU2D045
  • 4DU2D046

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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