The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1118-2019·Announced 2019-04-17

Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets 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 severity score under the rubric for significant potential health risks.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg. The recall involves 172,296 bottles of the 30-count and 90-count prescription-only medications. The products 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-Methylnitrosobutyric acid (NMBA) in the finished product at levels above the interim acceptable daily intake level.

Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for guidance. The affected lots include BEF8D058 (30-count) and various lots for the 90-count bottles with expiration dates ranging from March 2020 to November 2020.

The recalled product

Product
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen…
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
172,296

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 (20)

  • Count
  • lots
  • expiry: [30-count bottle] Lot BEF8D058
  • exp 11/30/2020 [90-count bottle] Lots BEF8D009
  • BEF8D010
  • BEF8D011
  • BEF8D012
  • BEF8D013
  • BEF8D007
  • BEF8D008
  • exp 3/31/2020
  • Lots BEF8D023
  • BEF8D024
  • BEF8D025
  • BEF8D020
  • BEF8D021
  • BEF8D022
  • exp 4/30/2020
  • Lots BEF8D054
  • BEF8D055

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 →

Related recalls

Same manufacturer · Torrent Pharma Inc.

See all →

Same hazard · impurity

See all →

Similar recalls