CLASS II Drug recall · Reported 2 Sep 2020 · FDA Enforcement Report

Losartan Potassium Tablets USP, 50 mg recalled

Hetero Labs Limited (Unit V) is recalling Losartan Potassium Tablets USP, 50 mg, distributed nationwide in the US. The recall was initiated on 6 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch # LOA19357A, exp. date 09/2021

Quantity recalled43,512 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-1545-2020
FDA event ID: 86191
Recalling firm: Hetero Labs Limited (Unit V), Badepalle, N/A
Classification: Class II
Status: Terminated
Recall initiated: 6 Aug 2020
FDA classified: 26 Aug 2020
Reported: 2 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Blood Pressure Medication

Timeline

6 Aug 2020	Recall initiated by company
26 Aug 2020	Classified by FDA	+20 days
2 Sep 2020	Published in enforcement report	+7 days

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

Reason for recall

Failed Tablet/Capsule Specification; complaint of bulging tablet

Product as listed by the FDA

Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India

Where it was distributed

Product was distributed to major wholesalers/distributors throughout the United States.

Nationwide

Questions about this recall

Why was it recalled?

Failed Tablet/Capsule Specification; complaint of bulging tablet

Which lots are affected?

Batch # LOA19357A, exp. date 09/2021

Where was it sold?

Product was distributed to major wholesalers/distributors throughout the United States.

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 Hetero Labs Limited (Unit V)

All 11

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Drug	CLASS II	Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium	Hetero Labs Limited (Unit V)	Other	Nationwide
3 Oct 2018Drug	CLASS I	Montelukast Sodium Tablets 10 mg recalled by Hetero Labs Limited Unit VMontelukast Sodium	Hetero Labs Limited Unit V	Packaging Defects	Nationwide
3 Oct 2018Drug	CLASS II	Montelukast Sodium Tablets, 10 mg* recalledMontelukast Sodium	Hetero Labs Limited Unit V	Other	Nationwide
29 Aug 2018Drug	CLASS II	Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg recalledValsartan	Hetero Labs Limited Unit V	Potency & Assay	Nationwide
29 Aug 2018Drug	CLASS II	Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg recalledValsartan	Hetero Labs Limited Unit V	Potency & Assay	Nationwide

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