The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1116-2019·Announced 2019-04-17

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, and the presence of a nitrosamine impurity (NMBA) above acceptable levels constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 100 mg, in 90-count and 1000-count bottles. The recall involves 121,668 bottles distributed nationwide in the United States and Puerto Rico.

The recall was initiated because FDA laboratory testing confirmed the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), in the finished product above the interim acceptable daily intake level. This finding represents a Current Good Manufacturing Practice (CGMP) deviation.

Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The affected lots and expiration dates are: 90-count bottles with Lots 4DU3E014 and 4DU3E015 (exp 1/31/2021), Lot 4DU3E065 (exp 7/31/2021); and 1000-count bottles with Lot 4DU3D018 (exp 11/30/2020), and Lots 4DU3E062 and 4DU3E063 (exp 6/30/2021).

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. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking…
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
121,668

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 (12)

  • Count
  • lots
  • expiry: [90-count bottle] Lots 4DU3E014
  • 4DU3E015
  • exp 1/31/2021
  • Lot 4DU3E065
  • exp 7/31/2021
  • [1000-count bottle] Lot 4DU3D018
  • exp 11/30/2020
  • Lots 4DU3E062
  • 4DU3E063
  • exp 6/30/2021

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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