Bisoprolol Fumarate and Hydrochlorothiazide Tablets recall
FDA recall D-0199-2026 · initiated Nov 21, 2025
Glenmark Pharmaceuticals Inc., USA recalled Bisoprolol Fumarate and Hydrochlorothiazide Tablets in Nov 2025 — an FDA Class III recall (D-0199-2026) because Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 11,136 bottles
Details
- Product
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
- Recalling company
- Glenmark Pharms
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Nov 21, 2025
- FDA report date
- Dec 10, 2025
Frequently asked
- Was Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Bisoprolol Fumarate and Hydrochlorothiazide Tablets in Nov 2025 — an FDA Class III recall (D-0199-2026) because Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0199-2026 was: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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: Nationwide in the USA. The recall covers these lots — Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026. 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-0199-2026.