The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1268-2019·Announced 2019-05-08

Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because FDA labs 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 agency classification is FDA Class II, and the presence of a nitrosamine impurity (NMBA) above acceptable levels represents a significant health risk, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg. The recall involves 54,084 bottles in 90-count and 1000-count packages. The product is prescription-only and was 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.

Consumers with this medication should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal. The specific lots and expiration dates are listed in the structured product information.

The recalled product

Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
54,084

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 (14)

  • Count
  • lots
  • expiry: [90-count bottle] Lot BX35D024
  • exp 1/31/2020
  • BEF8D060
  • BEF8D061
  • BEF8D062
  • BEF8D063
  • BEF8D064
  • exp 11/30/2020
  • [1000-count bottle] Lot BEF8D059
  • Lots BEF8E004
  • BEF8E005
  • exp 1/31/2021

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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