CLASS I Drug recall · Reported 14 Apr 2021 · FDA Enforcement Report
Telmisartan Tablets, USP 20 mg recalled by Alembic Pharmaceuticals
Alembic Pharmaceuticals is recalling Telmisartan Tablets, USP 20 mg, distributed nationwide in the US. The recall was initiated on 17 Mar 2021 and the FDA has classified it as Class I.
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-0326-2021
- FDA event ID
- 87533
- Recalling firm
- Alembic Pharmaceuticals, Tajpura, N/A
- Brand
- Telmisartan
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Mar 2021
- FDA classified
- 7 Apr 2021
- Reported
- 14 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 17 Mar 2021 | Recall initiated by company | |
| 7 Apr 2021 | Classified by FDA | +21 days |
| 14 Apr 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label-mixup
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Telmisartan Tablets, USP 20 mg recalled?
Yes. Alembic Pharmaceuticals recalled Telmisartan Tablets, USP 20 mg on 17 Mar 2021. The recall is Class I and its status is Terminated. Recall number D-0326-2021.
Why was it recalled?
Labeling: Label-mixup
Which lots are affected?
Lot #: 1905005661, Exp March 2022
Where was it sold?
Nationwide within the United States
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
More recalls from Alembic Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride | Alembic Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Celecoxib Capsules, 200 mg recalled by Alembic PharmaceuticalsCelecoxib | Alembic Pharmaceuticals | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09% | Alembic Pharmaceuticals | Sterility | 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/12.5 mg recalledTelmisartan And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Other | Nationwide |
| Drug | CLASS II | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg recalledTelmisartan And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Other | 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 |