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Class II · ModerateActive recall

Bisoprolol Fumarate And Hydrochlorothiazide

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # GBHL24005A, Exp Date: 09/2026
Where it was soldUS Nationwide and PR.
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

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

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 byUNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816 foreign manufacturer
Brand nameBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Generic nameBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Active ingredient(s)BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE
Distributed by / forUNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816
NDC29300-187-01
Show the full FDA record
Full product labelBisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
Recalling firmUnichem Pharmaceuticals USA Inc.
DistributionUS Nationwide and PR.
QuantityN/A
Recall initiated2026-01-21
Report date2026-02-11
Recall completed—
Recall numberD-0301-2026
ClassificationClass II
FDA statusOngoing
Origin on fileEast Brunswick 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.