FDAClass IIAugust 21, 2019

Lisinopril and Hydrochlorothiazide Tablets USP recall

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc.…

Why was Lisinopril and Hydrochlorothiazide Tablets USP recalled?

Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

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?

Batch# H900575, exp. date 01/2022

Product
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc.…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
39,216 bottles
Distribution
Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
Recall date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls