Reported Feb 11, 2026 · Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by:…
Unichem Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Unichem Pharmaceuticals USA Inc. · 1 Tower Center Blvd Ste 2200 · East Brunswick, NJ · 08816-1145
Is this the product you have?
- Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only
- Manufactured byUNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India
- Manufactured forUNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
- Lot codes and dates
- Lot # GBHL24005A
- Exp Date09/2026
- Amount recalled
- N/A
Where it was sold
- Nationwide
- PR
Why it was recalled
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
This product could cause temporary or reversible health problems — stop using it.
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