CLASS II ONGOING Drug recall · Reported 11 Feb 2026 · FDA Enforcement Report
Bisoprolol Fumarate and Hydrochlorothiazide tablets recalled
Unichem Pharmaceuticals USA is recalling Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, distributed nationwide in the US. The recall was initiated on 21 Jan 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0301-2026
- FDA event ID
- 98323
- Recalling firm
- Unichem Pharmaceuticals USA, East Brunswick, NJ
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jan 2026
- FDA classified
- 30 Jan 2026
- Reported
- 11 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 21 Jan 2026 | Recall initiated by company | |
| 30 Jan 2026 | Classified by FDA | +9 days |
| 11 Feb 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
US Nationwide and PR.
Questions about this recall
Why was it recalled?
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Which lots are affected?
Lot # GBHL24005A, Exp Date: 09/2026
Where was it sold?
US Nationwide and PR.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Bisoprolol recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Bisoprolol Fumarate And Hydrochlorothiazide Tablets 2.5 mg/6.25 mg recalledBisoprolol Fumarate And Hydrochlorothiazide | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Bisoprolol Fumarate tablets, 5 mg recalledBisoprolol Fumarate | Unichem Pharmaceuticals Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Bisoprolol Fumarate Tablet, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |