CLASS II ONGOING Drug recall · Reported 5 Sep 2018 · FDA Enforcement Report
Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg recalled
Torrent Pharma is recalling Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg per, distributed nationwide in the US. The recall was initiated on 17 Aug 2018 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-1138-2018
- FDA event ID
- 80847
- Recalling firm
- Torrent Pharma, Basking Ridge, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Aug 2018
- FDA classified
- 28 Aug 2018
- Reported
- 5 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 17 Aug 2018 | Recall initiated by company | |
| 28 Aug 2018 | Classified by FDA | +11 days |
| 5 Sep 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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
Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30
Where it was distributed
Nationwide USA
Questions about this recall
Is Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg per recalled?
Yes. Torrent Pharma recalled Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg per on 17 Aug 2018. The recall is Class II and its status is Ongoing. Recall number D-1138-2018.
Why was it recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
Batch: BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, BV84C009
Where was it sold?
Nationwide 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 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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|---|---|---|---|---|---|
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
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Other Amlodipine and valsartan recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) bottles recalled | Teva Pharmaceuticals U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Amlodipine and Valsartan Tablets 10 mg/320 mg (a) bottles recalled | Teva Pharmaceuticals U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) bottles recalled | Teva Pharmaceuticals U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) bottles recalled | Teva Pharmaceuticals U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Amlodipine and Valsartan Tablets, USP, 10 mg/160mg recalled | Torrent Pharma | Potency & Assay | Nationwide |