FDAClass IIMay 11, 2022

Losartan Potassium and Hydrochlorothiazide Tablets USP recall: Impurity Out of Spec

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09)…

Why was Losartan Potassium and Hydrochlorothiazide Tablets USP 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 # H001149 4/30/2022 68180-215-06 H001602 5/31/2022 68180-215-06 H001884 6/30/2022 68180-215-06 H002539 8/31/2022 68180-215-06 H100944 4/30/2023 68180-215-06 H101054 4/30/2023 68180-215-06 H001150 4/30/2022 68180-215-09 H001151 4/30/2022 68180-215-09 H001152 4/30/2022 68180-215-09 H001532 5/31/2022 68180-215-09 H001533 5/31/2022 68180-215-09 H001534 5/31/2022 68180-215-09 H001535 5/31/2022 68180-215-09 H001536 5/31/2022 68180-215-09 H001603 5/31/2022 68180-215-09 H001604 5/31/2022 68180-215-09 H001605 5/31/2022 68180-215-09 H001606 5/31/2022 68180-215-09 H001607 5/31/2022 68180-215-09 H001608 5/31/2022 68180-215-09 H001885 6/30/2022 68180-215-09 H001886 6/30/2022 68180-215-09 H001887 6/30/2022 68180-215-09 H001888 6/30/2022 68180-215-09 H002171 7/31/2022 68180-215-09 H002172 7/31/2022 68180-215-09 H002173 7/31/2022 68180-215-09 H002174 7/31/2022 68180-215-09 H002175 7/31/2022 68180-215-09 H002540 8/31/2022 68180-215-09 H002541 8/31/2022 68180-215-09 H002542 8/31/2022 68180-215-09 H002543 8/31/2022 68180-215-09 H002544 8/31/2022 68180-215-09 H002545 8/31/2022 68180-215-09 H002976 10/31/2022 68180-215-09 H002977 10/31/2022 68180-215-09 H002978 10/31/2022 68180-215-09 H003131 11/30/2022 68180-215-09 H003132 11/30/2022 68180-215-09 H003133 11/30/2022 68180-215-09 H003134 11/30/2022 68180-215-09 H003135 11/30/2022 68180-215-09 H003136 11/30/2022 68180-215-09 H100302 1/31/2023 68180-215-09 H100303 1/31/2023 68180-215-09 H100304 1/31/2023 68180-215-09 H100340 1/31/2023 68180-215-09 H100341 1/31/2023 68180-215-09 H100657 2/28/2023 68180-215-09 H100658 2/28/2023 68180-215-09 H100659 2/28/2023 68180-215-09 H100660 2/28/2023 68180-215-09 H100661 2/28/2023 68180-215-09 H100662 2/28/2023 68180-215-09 H100945 4/30/2023 68180-215-09 H100946 4/30/2023 68180-215-09 H101051 4/30/2023 68180-215-09 H101052 4/30/2023 68180-215-09 H101053 4/30/2023 68180-215-09 H101055 4/30/2023 68180-215-09 H101056 4/30/2023 68180-215-09 H101057 4/30/2023 68180-215-09 H101058 4/30/2023 68180-215-09 H101286 5/31/2023 68180-215-09 H101287 5/31/2023 68180-215-09 H101288 5/31/2023 68180-215-09 H101289 5/31/2023 68180-215-09 H101581 6/30/2023 68180-215-09 H101582 6/30/2023 68180-215-09 H101583 6/30/2023 68180-215-09 H101584 7/31/2023 68180-215-09 H101585 7/31/2023 68180-215-09 H101790 7/31/2023 68180-215-09 H101791 7/31/2023 68180-215-09 H102078 8/31/2023 68180-215-09 H102079 8/31/2023 68180-215-09 H102080 9/30/2023 68180-215-09 H102118 9/30/2023 68180-215-09 H102119 9/30/2023 68180-215-09 H102120 9/30/2023 68180-215-09 H102125 9/30/2023 68180-215-09 H102126 9/30/2023 68180-215-09

Product
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09)…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
1,214,016 bottles
Distribution
Product was distributed nationwide
Recall date
May 11, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls