FDAClass IIMay 4, 2022

Losartan Potassium Tab. USP 50mg recall: Impurity Out of Spec

Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.

Why was Losartan Potassium Tab. USP 50mg recalled?

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: E1321O, Exp.: 5/31/2023 Lot: E2521H, Exp.: 5/31/2023 Lot: E2621F, Exp.: 5/31/2023

Product
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
Recalling firm
Preferred Pharmaceuticals, Inc.
Quantity
44 Bottles of 90 Tablets 33 Bottles of 30 Tablets
Distribution
Nationwide within the U.S to CA, IN and FL.
Recall date
May 4, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls