FDAClass IIINovember 8, 2023

Bisoprolol Fumarate and Hydrochlorothiazide Tablets recall: Impurity Out of Spec

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited…

Why was Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled?

Failed Impurities/Degradation Specifications

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# 17212352, Exp 11/31/2023

Product
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited…
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Quantity
480 100-count bottles
Distribution
Nationwide in the USA
Recall date
November 8, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls