Bisoprolol Fumarate and Hydrochlorothiazide tablets 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.…
Why was Bisoprolol Fumarate and Hydrochlorothiazide tablets recalled?
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # GBHL24005A, Exp Date: 09/2026
- 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 date
- February 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)