The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0122-2020·Announced 2019-10-09

Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

Torrent Pharma Inc. is recalling Losartan Potassium Tablets 100 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 rating under the rubric, particularly given the presence of a nitrosamine impurity 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 39,432 bottles distributed nationwide in the United States and Puerto Rico. The affected lots are 4DU3E009 (expiring 12/31/2020) for the 90-count bottles and 4DU3D018 (expiring 02/28/2021) for the 1000-count bottles.

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 of 9.82 parts per million.

Consumers and healthcare providers should check their inventory for the specific NDCs, lot numbers, and expiration dates listed above. If the product matches the recalled items, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
39,432

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 (6)

  • Count
  • lot
  • expiry: [90 count] Lot 4DU3E009
  • exp 12/31/2020
  • [1000 count] Lot 4DU3D018
  • exp 02/28/2021

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 4 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 4 products in this recall →

Related recalls

Same manufacturer · Torrent Pharma Inc.

See all →

Same hazard · impurity

See all →

Similar recalls