The Recall Desk
SevereFDA (Drugs)·D-0503-2019·Announced 2019-02-27

Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

Torrent Pharma Inc. is recalling Losartan Potassium Tablets because FDA testing found the impurity NDEA 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 NDEA, a probable human carcinogen, above acceptable levels constitutes a significant health risk warranting a Severe rating.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 25 mg, 90-count bottles (NDC: 13668-113-90). The recall involves 43,416 bottles of Lot 4O49C013 with an expiration date of 09/2019. These prescription-only medications were 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-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The detected levels of NDEA exceeded the interim acceptable daily intake level of 0.083 parts per million.

Consumers and healthcare providers should stop using the affected Losartan Potassium Tablets and contact their healthcare provider for alternative treatment options. The recalled product should be returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
43,416

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 (4)

  • Count
  • lots
  • expiry: [90-count bottle] Lot 4O49C013
  • exp 09/2019

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 5 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 5 products in this recall →

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