CLASS III Drug recall · Reported 27 Apr 2016 · FDA Enforcement Report
Telmisartan Tablets, USP, 80 mg ( unit-dose blisters) recalled
Torrent Pharmaceuticals is recalling Telmisartan Tablets, USP, 80 mg ( unit-dose blisters) per, distributed nationwide in the US. The recall was initiated on 25 Feb 2016 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-0824-2016
- FDA event ID
- 73466
- Recalling firm
- Torrent Pharmaceuticals, Kadi, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Feb 2016
- FDA classified
- 18 Apr 2016
- Reported
- 27 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 25 Feb 2016 | Recall initiated by company | |
| 18 Apr 2016 | Classified by FDA | +53 days |
| 27 Apr 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Which lots are affected?
Lot#: BBV8B002R, Exp 12/16
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 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.
Other Telmisartan recalls
All 11| 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., USA | Other | Nationwide |
| Drug | CLASS II | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg recalledTelmisartan And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS I | Telmisartan Tablets, USP 20 mg recalled by Alembic PharmaceuticalsTelmisartan | Alembic Pharmaceuticals | Packaging Defects | Nationwide |