Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent
Torrent Pharma recalls 5mg/320mg Amlodipine and Valsartan tablets due to detected carcinogen impurity in manufacturing. Affected batches include BV84D010 through BV84C009. No remedy specified in official recall.
Recall notice
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Contact the company & request your remedy
What happened, in plain English
Torrent Pharma is recalling certain Amlodipine and Valsartan tablets because a carcinogen impurity was found in the manufacturing process. This could potentially lead to cancer risk with long-term use, though the recall does not specify a remedy. Read more at govinfonow.com/recall/39712-torrent-amlodipine-valsartan-tablets-recall-carcinogen-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39712-torrent-amlodipine-valsartan-tablets-recall-carcinogen-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1138-2018
Cite this page
“Torrent Amlodipine/Valsartan Tablets Recall: Carcinogen Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39712-torrent-amlodipine-valsartan-tablets-recall-carcinogen-impurity-risk. Based on FDA recall #D-1138-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1138-2018%22&limit=1).
Why it’s dangerous
The recall states a carcinogen impurity was detected in the active pharmaceutical ingredient used to make these drugs. This impurity could potentially lead to cancer risk with long-term use of the medication. The impurity was found during manufacturing quality control checks.
Who’s affected
Prescription patients who received the specific batch numbers of Amlodipine and Valsartan tablets from Torrent Pharmaceuticals. Those with the NDC 13668-205-30 and batch numbers listed in the recall are most at risk.
How to tell if you have this one
Check for the NDC code 13668-205-30 on the packaging. Look for batch numbers listed in the recall: BV84D010 through BV84C009. These tablets are prescription-only and sold by Torrent Pharmaceuticals.
- Brand
Torrent- Category
Drug
All 12 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1134-2018 | Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90; Batch: BV46C007, BV46C008, BV46C009, BV46C010, BV46C011, BV46C012, BV46C003, BV46C006 | 24468 bottles |
| D-1135-2018 | Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90; Batch: BV47C005, BV47C006, BV47D001, BV47C003, BV47C004 | 14016 bottles |
| D-1136-2018 | Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90; Batch: BV48D001, BV48D002 | ALL |
| D-1137-2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30; Batch: BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, BV77C010 | 89616 bottles |
| D-1138-2018 | 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; Batch: BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, BV84C009 | 66864 bottles |
| D-1139-2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30; Batch: BV65D002, BV65C002, BV65C003, BV65C004, BV65D001 | 46272 bottles |
| D-1140-2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30; Batch: BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, BV53C005 | 78144 bottles |
| D-1141-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30; Batch: BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2C007 | 169,200 bottles |
| D-1142-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30; Batch: BBY1E001, BBY1E003, BBY1C002, BBY1E002, BBY1D001 | 50,784 bottles |
| D-1143-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30; Batch: BBY2E001, BBY2D001, BBY2D002 | 22704 bottles |
| D-1144-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30; Batch: BBX9D004, BBX9E001, BBX9D001, BBX9D002, BBX9D003 | 34320 bottles |
| D-1145-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30; Batch: BBY4D004, BBY4E001, BBY4D001, BBY4D002, BBY4D003 | 37704 bottles |
What to do — step by step
Check Product Details
Look for the NDC code 13668-205-30 and batch numbers BV84D010 through BV84C009 on the packaging.
Questions people ask
Is there a remedy for this recall?
The official recall does not specify any remedy.
What batch numbers are affected?
Batch numbers BV84D010 through BV84C009 are affected.
How can I tell if I have the recalled product?
Check for the NDC code 13668-205-30 and batch numbers listed in the recall (BV84D010 through BV84C009).
Contact Torrent
We’ve drafted a message you can send Torrent to request your refund or repair — edit it as you like.
Subject: Recall D-1138-2018 — Torrent Torrent Hello, I own a Torrent that is covered by recall D-1138-2018 from Torrent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1138-2018 (August 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1138-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.