Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bisoprolol Fumarate and Hydrochlorothiazide tablets Recalled by Unichem Pharmaceuticals USA Inc. Due to cGMP Deviations: recall due to not meeting the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Unichem Pharmaceuticals USA Inc. directly.
Affected Products
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
Quantity: N/A
Why Was This Recalled?
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Unichem Pharmaceuticals USA Inc.
Unichem Pharmaceuticals USA Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report