The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1115-2019·Announced 2019-04-17

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.

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 for significant potential health risks.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 50 mg, in 30-count, 90-count, and 1000-count bottles. The recall affects 476,340 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 check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on replacement medication.

The recalled product

Product
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150…
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
476,340

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 4DU2D077
  • exp 10/31/2020
  • [90-count bottle] Lot 4DU2D087
  • Lots 4DU2E023
  • 4DU2E024
  • 4DU2E026
  • 4DU2E027
  • 4DU2E028
  • 4DU2E029
  • 4DU2E020
  • exp 1/31/2021
  • Lots 4O50E007
  • 4O50E008
  • exp 8/31/2021
  • [1000 count bottle] Lots 4DU2D067
  • 4DU2D069
  • 4DU2D063
  • 4DU2D064

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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