Unichem recalls bisoprolol and hydrochlorothiazide tablets over impurity above allowed limit
The tablets contain an impurity called N-Nitroso Bisoprolol that does not meet the allowed limit, because of manufacturing practice problems.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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
- Hazard
- cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
- Units
- N/A
- Where sold
- US Nationwide and PR.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- January 30, 2026
- Recall started
- January 21, 2026
- FDA enforcement report
- February 11, 2026
- Identifiers
- Codes: Lot # GBHL24005A, Exp Date: 09/2026
- FDA recall number: D-0301-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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
- Reason for recall
- cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide and PR.
- Quantity
- N/A
Related recalls
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The recalled 500-count bottles of 5 mg tablets are subpotent, meaning they contain less of the drug than they should, and 10,875 bottles were distributed nationwide.
Unichem Pharmaceuticals USA Inc. · 10,875 Bottles