FDAFDA · Food and drugs·Recall number D-0301-2026
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
Published February 11, 2026 · Recall initiated: January 21, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Unichem Pharmaceuticals USA Inc.
- Distributor
- US Nationwide and PR.
- Lot
- Lot # GBHL24005A, Exp Date: 09/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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