The Recall Desk
SevereFDA (Drugs)·D-1264-2019·Announced 2019-05-08

Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

Torrent Pharma Inc. is recalling Losartan Potassium 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 daily intake 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 Tablets, USP, 25 mg. The affected products are available in 90-count and 1000-count bottles and are prescription-only. The recall involves 28,464 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 with these specific products should stop using them and contact their healthcare provider or pharmacist for guidance. The affected lots include BDK1C003 and BDK1C002 (expiring 07/31/2019) and lots 4DU1D004, 4DU1D005, and 4DU1D006 (expiring 12/31/2019).

The recalled product

Product
Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) 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
28,464

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 (9)

  • Count
  • lots
  • expiry: [90-count bottle] Lot BDK1C003
  • exp 07/31/2019
  • [1000-count bottle] Lot BDK1C002
  • Lots 4DU1D004
  • 4DU1D005
  • 4DU1D006
  • exp 12/31/2019

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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