Unichem bisoprolol/hydrochlorothiazide tablets recalled for impurity
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 1 Tower Center Blvd Ste 2200, N/A, East Brunswick, NJ, United States
- Classification
- Class II
- Recall number
- D-0301-2026
In the FDA's words
- Description
- 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 cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. Lot # GBHL24005A, Exp Date: 09/2026 Distribution: US Nationwide and PR. Affected quantity: N/A
- Hazard
- cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.