CLASS II Drug recall · Reported 6 Aug 2014 · FDA Enforcement Report

Losartan Potassium and Hydrochlorothiazide Tablets recalled

Jubilant Cadista Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg per, distributed nationwide in the US. The recall was initiated on 11 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #14P0292, Exp 04/2016

NDC59746-337, 59746-338, 59746-339

UPC0359746338107, 0359746337100, 0359746339104

Quantity recalled9,358 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1500-2014
FDA event ID: 68776
Recalling firm: Jubilant Cadista Pharmaceuticals, Salisbury, MD
Brand: Losartan Potassium And Hydrochlorothiazide
Manufacturer: Jubilant Cadista Pharmaceuticals Inc.
Classification: Class II
Status: Terminated
Recall initiated: 11 Jul 2014
FDA classified: 31 Jul 2014
Reported: 6 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Foreign Material
Drug class: Blood Pressure Medication

Timeline

11 Jul 2014	Recall initiated by company
31 Jul 2014	Classified by FDA	+20 days
6 Aug 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

Which lots are affected?

Lot #14P0292, Exp 04/2016

Where was it sold?

Nationwide and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Jubilant Cadista Pharmaceuticals

All 31

Reported	Class	Recall	Company	Reason	Where
11 Jan 2023Drug	CLASS III	Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
13 Apr 2022Drug	CLASS III	Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
6 Apr 2022Drug	CLASS I	Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride	Jubilant Cadista Pharmaceuticals	Labeling Errors	5 states

Other Losartan recalls

All 97

Reported	Class	Recall	Company	Reason	Where
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma USA	Foreign Material	Nationwide
12 Jul 2023Drug	CLASS II	Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium	Strides Pharma	Foreign Material	Nationwide
6 Jul 2022Drug	CLASS II	Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 25 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide