FDA-Drug2026-02-11Class IICHEMICAL
Unichem Pharmaceuticals bisoprolol/hydrochlorothiazide tablets recalled for elevated impurity levels
HEAVY METALSNationwide distribution
Stop using Unichem bisoprolol/hydrochlorothiazide tablets
Unichem Pharmaceuticals is recalling one lot of bisoprolol fumarate and hydrochlorothiazide tablets (2.5 mg/6.25 mg) because they contain higher-than-allowed levels of N-Nitroso Bisoprolol, a potentially harmful impurity. The affected lot was manufactured in India and distributed nationwide.
- Check your bisoprolol/hydrochlorothiazide bottle for lot number GBHL24005A with expiration date 09/2026.
- If you have this lot, contact your pharmacy or doctor before stopping the medication.
- Do not abruptly stop taking your blood pressure medication without medical guidance.
- Return the affected medication to your pharmacy or follow FDA disposal instructions.
Hazard
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Sold states
US Nationwide and PR.
Affected count
N/A
Manufactured in
1 Tower Center Blvd Ste 2200, N/A, East Brunswick, NJ, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0301-2026Don't want to check this manually?
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