FDAHealthJanuary 21, 2026
Unichem Pharmaceuticals USA Inc. — 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,
⚠️ cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 21, 2026
US Nationwide and PR.
What's affected?
- 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
- Lot code
- GBHL24005A
Additional details
Lot # GBHL24005A, Exp Date: 09/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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