Unichem Pharmaceuticals USA recalls 2.5mg/6.25mg Bisoprolol Fumarate and Hydrochlorothiazide tablets due to N-Nitroso Bisoprolol impurity exceeding safety limits. Affected products were manufactured in India and shipped to US. Consumers should contact pharmacy for replacement.
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Unichem Pharmaceuticals USA is recalling 100-count bottles of Bisoprolol Fumarate and Hydrochlorothiazide tablets (2.5mg/6.25mg) because they contain an impurity that could be unsafe. This recall is due to manufacturing issues that didn't meet safety standards for a specific chemical impurity.
The tablets were manufactured with a chemical impurity called N-Nitroso Bisoprolol that exceeds safe limits. This impurity could potentially cause health issues if the medication is taken as directed, though the exact risk level isn't specified in the recall notice.
Prescription patients who received the recalled tablets from pharmacies or doctors. People with high blood pressure or heart conditions who take these medications are most at risk.
Check for the 100-count bottle labeled 'Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg'. The product was manufactured by Unichem Laboratories in India and shipped to US under NDC 29300-187-01. Lot number GBHL24005A with expiration date 09/2026.
Talk to your pharmacy about returning the recalled tablets for a safe replacement.
The recall is due to manufacturing issues that caused the tablets to contain an impurity called N-Nitroso Bisoprolol that exceeds safe limits.
Check for the 100-count bottle labeled 'Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg' with NDC 29300-187-01 and lot number GBHL24005A.
Contact your pharmacy to return the tablets for a safe replacement.
We’ve drafted a message you can send Unichem to request your refund or repair — edit it as you like.
Subject: Recall D-0301-2026 — Unichem Unichem Hello, I own a Unichem that is covered by recall D-0301-2026 from Unichem. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
