Bisoprolol Fumarate and Hydrochlorothiazide tablets recall
FDA recall D-0301-2026 · initiated Jan 21, 2026
Unichem Pharmaceuticals USA Inc. recalled Bisoprolol Fumarate and Hydrochlorothiazide tablets in Jan 2026 — an FDA Class II recall (D-0301-2026) because cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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
- Recalling company
- Unichem Labs Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide and PR.
- Initiated
- Jan 21, 2026
- FDA report date
- Feb 11, 2026
Frequently asked
- Was Bisoprolol Fumarate and Hydrochlorothiazide tablets recalled?
- Unichem Pharmaceuticals USA Inc. recalled Bisoprolol Fumarate and Hydrochlorothiazide tablets in Jan 2026 — an FDA Class II recall (D-0301-2026) because cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Bisoprolol Fumarate and Hydrochlorothiazide tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0301-2026 was: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
- Is a recalled Bisoprolol Fumarate and Hydrochlorothiazide tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Bisoprolol Fumarate and Hydrochlorothiazide tablets are affected?
- Distributed: US Nationwide and PR.. The recall covers these lots — Lot # GBHL24005A, Exp Date: 09/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0301-2026.