CLASS II Drug recall · Reported 17 Aug 2022 · FDA Enforcement Report
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg recalled
Glenmark Pharmaceuticals Inc., U is recalling Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, distributed nationwide in the US. The recall was initiated on 29 Jun 2022 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-1306-2022
- FDA event ID
- 90541
- Recalling firm
- Glenmark Pharmaceuticals Inc., U, Mahwah, NJ
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2022
- FDA classified
- 5 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 29 Jun 2022 | Recall initiated by company | |
| 5 Aug 2022 | Classified by FDA | +37 days |
| 17 Aug 2022 | 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
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Product as listed by the FDA
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13.
Where it was distributed
nationwide
Questions about this recall
Is Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg recalled?
Yes. Glenmark Pharmaceuticals Inc., U recalled Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg on 29 Jun 2022. The recall is Class II and its status is Terminated. Recall number D-1306-2022.
Why was it recalled?
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Which lots are affected?
Lots 17210929 & 17210930, Exp Date 05/2023; Lot 17211203, Exp Date 06/2023 & Lots 17211643, 17211646 & 17211649, Exp Date 08/2023
Where was it sold?
nationwide
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 21 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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|---|---|---|---|---|---|
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| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., U | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |
Other Telmisartan recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Telmisartan Tablets, USP 40mg recalled by Micro Labs | Micro Labs | Potency & Assay | PR, RI, TN |
| Drug | CLASS II | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg recalledTelmisartan And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Other | Nationwide |
| Drug | CLASS I | Telmisartan Tablets, USP 20 mg recalled by Alembic PharmaceuticalsTelmisartan | Alembic Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Telmisartan and Amlodipine Tablets 80 mg/5 mg recalledTelmisartan And Amlodipine | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Telmisartan Tablets, USP, 80 mg ( unit-dose blisters) recalled | Torrent Pharmaceuticals | Foreign Material | Nationwide |