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Drug recall · FDA · Published August 17, 2018

Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

🇺🇸 FDA recall #D-1138-2018DrugTorrent Pharma Inc. ›
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Contact the company & request your remedy

Recalling firmTorrent Pharma Inc.150 Allen Rd Ste 102, N/A · Basking Ridge, NJ 07920-3856
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
Write-up in progress

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We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.

Source Page by GovInfoNow · govinfonow.com/recall/39712-torrent-pharma-inc-recalls-amlodipine-and-valsartan-tablets-usp-5 · Recall date August 17, 2018 · FDA enforcement record: FDA #D-1138-2018

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“Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent.” GovInfoNow, recall dated August 17, 2018. https://govinfonow.com/recall/39712-torrent-pharma-inc-recalls-amlodipine-and-valsartan-tablets-usp-5. Based on FDA recall #D-1138-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1138-2018%22&limit=1).

How to tell if you have this one

  • Brand
    Torrent Pharma Inc.
  • Category
    Drug
FDA recall event · 12 products

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 numberProduct, codes & lotsQuantity
D-1134-2018Valsartan 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, BV46C00624468 bottles
D-1135-2018Valsartan 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, BV47C00414016 bottles
D-1136-2018Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90; Batch: BV48D001, BV48D002ALL
D-1137-2018Amlodipine 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, BV77C01089616 bottles
D-1138-2018Amlodipine 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, BV84C00966864 bottles
D-1139-2018Amlodipine 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, BV65D00146272 bottles
D-1140-2018Amlodipine 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, BV53C00578144 bottles
D-1141-2018Amlodipine, 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, BBX2C007169,200 bottles
D-1142-2018Amlodipine, 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, BBY1D00150,784 bottles
D-1143-2018Amlodipine, 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, BBY2D00222704 bottles
D-1144-2018Amlodipine, 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, BBX9D00334320 bottles
D-1145-2018Amlodipine, 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, BBY4D00337704 bottles
Take action

Contact Torrent Pharma Inc.

We’ve drafted a message you can send Torrent Pharma Inc. to request your refund or repair — edit it as you like.

✉️ Open in email
Subject: Recall D-1138-2018 — Torrent Pharma Inc. Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg,

Hello,

I own a Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent that is covered by recall D-1138-2018 from Torrent Pharma Inc..

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.

Similar recalls

RemedyRepack Inc. recalls Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma
RemedyRePack Inc. · 89% matchAVKARE Inc. recalls Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc.
AVKARE Inc. · 88% matchPreferred Pharmaceuticals, Inc recalls Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250
Preferred Pharmaceuticals, Inc. · 88% matchA-S Medication Solutions LLC. recalls Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx
A-S Medication Solutions LLC · 87% matchPrinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only,
Prinston Pharmaceutical Inc · 87% match

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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.
  • 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA