Class II · Moderate risk
Bisoprolol Fumarate and Hydrochlorothiazide tablets
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Is Bisoprolol recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Bisoprolol (7 total). Check the affected lots below.
Most common reason: Impurity / degradation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bisoprolol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Bisoprolol recalls in 2026
1 initiated in 2026, 7 in total — newest first
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Bisoprolol Fumarate tablets
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class II · Moderate risk
Zebeta¿ (bisoprolol fumarate)
Failed Dissolution Specifications: OOS result during stability testing
Class II · Moderate risk
BISOPROLOL FUMARATE Tablet
Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree: AD34934_4, EXP: 5/10/2014.
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