United StatesBisoprolol Fumarate and Hydrochlorothiazide tablets, USP 2.5 mg/6.25 mg in 100‑count Rx bottles (NDC 29300‑187‑01), Lot GBHL24005A, exp. 09/2026, manufactured by Unichem Laboratoris Ltd. for Unichem Pharmaceuticals USA Inc., are affected. The product was recalled because it did not meet the N‑Nitroso Bisoprolol impurity specification limits (cGMP deviations); the recall covers sales nationwide in the U.S. and Puerto Rico.
What's being recalled
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
Recalling firm: Unichem Pharmaceuticals USA Inc., East Brunswick, NJ, United States.
How to identify it
Lot # GBHL24005A, Exp Date: 09/2026
The hazard
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide and PR.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)