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.
“Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall: N-Nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31528-unichem-bisoprolol-hydrochlorothiazide-tablets-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0301-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0301-2026%22&limit=1).
The FDA announced on Jan. 21, 2026, that Unichem Pharmaceuticals USA Inc. is recalling Bisoprolol Fumarate and Hydrochlorothiazide tablets due to cGMP deviations involving N-Nitroso Bisoprolol impurity limits. The recall covers 100-count bottles distributed nationwide.
How to tell if you have it
Brand: Unichem
Product: Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg
Packaging: 100-count bottle
NDC: 29300-187-01
Lot #: GBHL24005A
Expiration Date: 09/2026
The hazard
The recall is due to the product not meeting the N-Nitroso Bisoprolol impurity specification limits. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Unichem Pharmaceuticals USA Inc. has 11 other recalls on record since July 30, 2015. Other recent recalls of similar products include Unichem busPIRone 5mg Tablets Recall (April 13, 2026), Unichem Recalls Doxazosin 4mg Tablets Due to Wrong ID Imprint (Jan. 21, 2026), and Unichem Cyclobenzaprine Tablets Recalled Due to Label Mix-Up (Aug. 27, 2025). Other recent recalls of similar products include Glenmark Bisoprolol/Hydrochlorothiazide Tablets Recall (Nov. 21, 2025), Asclemed Duloxetine Capsules Recall (May 14, 2026), and Breckenridge Duloxetine Capsules Recall (June 4, 2026).
How to tell if you have this one
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.
Brand
Unichem
Category
Drug
Based on the official FDA remedy
What to do — step by step
Contact Pharmacy
Talk to your pharmacy about returning the recalled tablets for a safe replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide and PR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 21 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #D-0301-2026 (January 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0301-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.