CLASS III Drug recall · Reported 8 Nov 2023 · FDA Enforcement Report
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg recalled
Glenmark Pharmaceuticals Inc., USA is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, distributed nationwide in the US. The recall was initiated on 20 Oct 2023 and the FDA has classified it as Class III.
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-0085-2024
- FDA event ID
- 93252
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Manufacturer
- GLENMARK PHARMACEUTICALS INC., USA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Oct 2023
- FDA classified
- 2 Nov 2023
- Reported
- 8 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 20 Oct 2023 | Recall initiated by company | |
| 2 Nov 2023 | Classified by FDA | +13 days |
| 8 Nov 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot# 17212352, Exp 11/31/2023
Where was it sold?
Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Bisoprolol recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Unichem Pharmaceuticals USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | 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 |