Bisoprolol Fumarate and Hydrochlorothiazide Tablets 2.5 mg/6.25 mg
Unichem Pharmaceuticals recalls Bisoprolol/Hydrochlorothiazide 2.5/6.25 mg tablets (NDC 29300-187-01) due to N-Nitroso Bisoprolol impurity specification failure.
Do not use this medication. Contact your pharmacy or healthcare provider immediately for a replacement or alternative blood pressure medication. Return the recalled product to your pharmacy.
Why it was recalled
Unichem Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg (NDC 29300-187-01, 100-count bottles) due to cGMP deviations: the product does not meet N-Nitroso Bisoprolol impurity specification limits. The affected medication was distributed nationwide and in Puerto Rico.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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
- Recall #
- D-0301-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Unichem Pharmaceuticals USA Inc.
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification