CLASS III Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Telmisartan and Amlodipine Tablets 80 mg/5 mg recalled
Lupin Pharmaceuticals is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg, distributed nationwide in the US. The recall was initiated on 1 Apr 2019 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-1121-2019
- FDA event ID
- 82528
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Apr 2019
- FDA classified
- 11 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 1 Apr 2019 | Recall initiated by company | |
| 11 Apr 2019 | Classified by FDA | +10 days |
| 17 Apr 2019 | 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; 18 month long term stability study.
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
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06
Where it was distributed
Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Which lots are affected?
G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
Where was it sold?
Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout 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 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 Lupin Pharmaceuticals
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
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 |