The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0502-2019·Announced 2019-02-27

Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing found the impurity N-nitrosodimethylamine (NDEA) 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, and the rubric specifies that FDA Class II recalls involving significant health risks or specific impurity concerns like NDEA are categorized as Severe.

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 involves 65,832 bottles distributed nationwide in the United States and Puerto Rico. Specific lot numbers and expiration dates are listed in the product details.

The recall was initiated because FDA laboratory testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient used to manufacture the product. The levels of NDEA were found to be above the interim acceptable daily intake level of 0.083 parts per million. This constitutes a Current Good Manufacturing Practice (CGMP) deviation.

Consumers who have these specific bottles of Losartan Potassium Tablets should stop using them and contact their healthcare provider for guidance on alternative treatment options. The recalled product is prescription-only.

The recalled product

Product
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
65,832

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 (8)

  • Count
  • lots
  • expiry: [30-count bottle] Lot 4L67C035
  • exp 10/2019
  • [90-count bottle] Lot 4L67C035
  • 4L67C036 exp 10/2019
  • [1000-count bottle] Lot 4O50C005
  • exp 11/2019

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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