The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1266-2019·Announced 2019-05-08

Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 100 mg, because FDA labs confirmed the presence of the impurity NMBA 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, which corresponds to a Severe severity score under the rubric, particularly given the presence of a carcinogenic impurity (NMBA) above acceptable limits.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 100 mg, in 90-count and 1000-count bottles. The recall involves 65,184 bottles distributed nationwide in the United States and Puerto Rico. The affected lots include 4DU3E016, 4DU3C012, 4DU3C015, 4DU3C016, 4DU3C017, 4DU3C031, 4DU3D007, 4DU3D008, 4DU3E017, and 4DU3E019, with expiration dates ranging from July 31, 2019, to February 28, 2021.

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 exceeding the interim acceptable daily intake limit.

Consumers and healthcare providers should stop using the recalled medication and contact their healthcare provider for a replacement. Patients should not discontinue their prescribed treatment without consulting their doctor.

The recalled product

Product
Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) 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
65,184

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 (19)

  • Count
  • lots
  • expiry: [90-count bottle] Lot 4DU3E016
  • exp 01/31/2021
  • [1000-count bottle] Lot 4DU3C012
  • exp 7/31/2019
  • Lots 4DU3C015
  • 4DU3C016
  • 4DU3C017
  • exp 8/31/2019
  • Lot 4DU3C031
  • exp 9/30/2019
  • Lots 4DU3D007
  • 4DU3D008
  • exp 1/31/2020
  • Lot 4DU3E017
  • exp 1/31/2021
  • Lot 4DU3E019
  • exp 2/28/2021

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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