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Class III · Lower riskRecall completed

Bisoprolol Fumarate And Hydrochlorothiazide

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot# 17212352, Exp 11/31/2023
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430 foreign manufacturer
Brand nameBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Generic nameBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Active ingredient(s)BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE
Distributed by / forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
NDC68462-879-01
Show the full FDA record
Full product labelBisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionNationwide in the USA
Quantity480 100-count bottles
Recall initiated2023-10-20
Report date2023-11-08
Recall completed2024-08-16
Recall numberD-0085-2024
ClassificationClass III
FDA statusTerminated
Origin on fileMahwah NJ United States

Related

Hydrochlorothiazide recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.