Quick Facts at a Glance
- Recall Date
- January 21, 2026
- Hazard Level
- HIGH
- Brands
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, Unichem Pharmaceuticals (USA), Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, Unichem Pharmaceuticals (USA), Inc.
- Product type
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets
- Model numbers
- Lot # GBHL24005A, Exp Date: 09/2026
- UPC codes
- 29300-187, 29300-188, 29300-189, 29300-187-13, 29300-187-01, 29300-187-05, 29300-187-10, 29300-188-13 +5 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 21, 2026
Reported by FDA DRUG
February 11, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Unichem Pharmaceuticals USA Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Bisoprolol Fumarate and Hydrochlorothiazide tablets are used to treat high blood pressure and heart failure. Consumers often buy these medications to manage chronic health conditions effectively.
Why This Is Dangerous
The recall was issued due to the presence of N-Nitroso Bisoprolol, which can cause serious health issues if consumed over time. This impurity indicates a failure to meet safety manufacturing standards.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers are urged to stop using this medication immediately, which can cause inconvenience and health concerns for those relying on it for managing their health.
Practical Guidance
How to identify if yours is affected
- Check the lot number on your bottle against the recall notice.
- Confirm the expiration date is September 2026.
- If in doubt, contact your pharmacy or healthcare provider.
Where to find product info
The lot number and expiration date are typically printed on the label of the prescription bottle.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Contact Unichem Pharmaceuticals directly via their customer service number.
- Document all communications in case of disputes.
How to prevent similar issues
- Inquire about the impurity testing of medications before purchase.
- Consult with your healthcare provider about alternative medications.
- Look for brands with strong safety records.
Documentation advice
Keep a copy of your prescription, any communication from Unichem, and photos of the product for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall involves Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, in 100-count bottles. These tablets are prescribed only and were manufactured by Unichem Laboratoris Ltd. The affected lot number is GBHL24005A with an expiration date of September 2026.
Key Facts
- Recall date: January 21, 2026
- Classification: Class II
- Impurity risk: N-Nitroso Bisoprolol
- Lot number: GBHL24005A
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.