Bisoprolol Fumarate and Hydrochlorothiazide tablets 2.5 mg/6.25mg Recall: Impurity Out of Spec
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD.…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Bisoprolol Fumarate recalled?
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Bisoprolol 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
Which lot codes, UPCs or models are affected?
Lot # GBHL24005A, Exp Date: 09/2026
- Agency record number
- D-0301-2026
- Product
- Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD.…
- Recalling firm
- Unichem Pharmaceuticals USA Inc.
- Quantity
- N/A
- Distribution
- US Nationwide and PR.
- Recall started
- January 21, 2026
- Report date
- February 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)