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
Reported: February 11, 2026 Initiated: January 21, 2026 #D-0301-2026
Product 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
Reason for Recall
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Details
- Recalling Firm
- Unichem Pharmaceuticals USA Inc.
- Units Affected
- N/A
- Distribution
- US Nationwide and PR.
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was 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. Recalled by Unichem Pharmaceuticals USA Inc.. Units affected: N/A.
Why was this product recalled? ▼
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 11, 2026. Severity: Moderate. Recall number: D-0301-2026.
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