CLASS II Drug recall · Reported 15 Jul 2015 · FDA Enforcement Report

Losartan potassium tablets USP, 50 mg recalled by Apotex

Apotex is recalling Losartan potassium tablets USP, 50 mg, distributed nationwide in the US. The recall was initiated on 29 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: KN1449, Exp 06/2015

Quantity recalled23,076 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-1214-2015
FDA event ID: 71418
Recalling firm: Apotex, Toronto, N/A
Classification: Class II
Status: Terminated
Recall initiated: 29 May 2015
FDA classified: 7 Jul 2015
Reported: 15 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Blood Pressure Medication

Timeline

29 May 2015	Recall initiated by company
7 Jul 2015	Classified by FDA	+39 days
15 Jul 2015	Published in enforcement report	+8 days

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

Reason for recall

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Product as listed by the FDA

Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9

Where it was distributed

Nationwide, Hawaii and Puerto Rico

Nationwide Hawaii Puerto Rico

Questions about this recall

Why was it recalled?

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Which lots are affected?

Lot #: KN1449, Exp 06/2015

Where was it sold?

Nationwide, Hawaii 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.

Other products in this recall event

3 other products · FDA event 71418

This product is part of a recall event; the main page for the event is Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg recalled.

Reported	Class	Recall	Company	Reason	Where
15 Jul 2015	CLASS II	Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg recalled	Apotex	Other	Nationwide
15 Jul 2015	CLASS II	Losartan potassium tablets USP, 25 mg recalled by Apotex	Apotex	Other	Nationwide
15 Jul 2015	CLASS II	Losartan potassium tablets USP, 100 mg recalled by Apotex	Apotex	Other	Nationwide

More recalls from Apotex

All 75

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25 Mar 2026Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
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8 Oct 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide

Other Losartan recalls

All 98

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