Unichem Bisoprolol Tablets Recall: Unknown Impurity Risk
Unichem Pharmaceuticals recalls 5mg Bisoprolol Fumarate tablets due to potential impurity during stability testing. Affected lots manufactured in India, expiring 2017-2018. No specific remedy provided in recall notice.
Recall notice
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Contact the company
What happened, in plain English
Unichem Pharmaceuticals is recalling 5mg Bisoprolol Fumarate tablets that may contain an unknown impurity detected during stability testing. This could pose a health risk if the tablets are taken as prescribed. Read more at govinfonow.com/recall/41160-unichem-bisoprolol-tablets-recall-unknown-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41160-unichem-bisoprolol-tablets-recall-unknown-impurity-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0010-2018
Cite this page
“Unichem Bisoprolol Tablets Recall: Unknown Impurity Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41160-unichem-bisoprolol-tablets-recall-unknown-impurity-risk. Based on FDA recall #D-0010-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0010-2018%22&limit=1).
Why it’s dangerous
During stability testing, an unknown impurity was found in the tablets. This could potentially affect the medication's safety and effectiveness if taken as prescribed.
Who’s affected
Prescription holders of the 5mg Bisoprolol Fumarate tablets with lot numbers GBOL16001, GBOL16002 (expiring Dec 2017) or GBOL16015 (expiring Mar 2018) are affected. Patients taking this medication should contact their doctor.
How to tell if you have this one
Check for the 5mg Bisoprolol Fumarate tablets in 30-count bottles with lot numbers GBOL16001, GBOL16002 (expiring Dec 2017) or GBOL16015 (expiring Mar 2018).
- Brand
Unichem- Category
Drug
What to do — step by step
Check Medication Details
Verify the lot number and expiration date on the tablet packaging to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0010-2018 (October 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0010-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.