CLASS II ONGOING Drug recall · Reported 5 Sep 2018 · FDA Enforcement Report

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg recalled

Torrent Pharma is recalling Amlodipine and Valsartan Tablets, USP, 5 mg/160 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

Lot, batch or date codesBatch: BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, BV53C005

Quantity recalled78144 bottles

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-1140-2018
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/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30

Where it was distributed

Nationwide USA

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Batch: BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, BV53C005

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 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 products in this recall event

11 other products · FDA event 80847

This product is part of a recall event; the main page for the event is Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg recalled.

Reported	Class	Recall	Company	Reason	Where
5 Sep 2018	CLASS II	Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg recalled	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Amlodipine, Valsartan and Hydrochlorothiazide Tablets recalled	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg recalled	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Valsartan Tablets USP, 160mg recalled by Torrent Pharma	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Amlodipine, Valsartan and Hydrochlorothiazide Tablets recalled	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Valsartan Tablets USP, 320mg recalled by Torrent Pharma	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Valsartan Tablets USP, 80mg recalled by Torrent Pharma	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Amlodipine, Valsartan and Hydrochlorothiazide Tablets recalled	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Amlodipine and Valsartan Tablets, USP, 10 mg/160mg recalled	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Amlodipine, Valsartan and Hydrochlorothiazide Tablets recalled	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018	CLASS II	Amlodipine, Valsartan and Hydrochlorothiazide Tablets recalled	Torrent Pharma	Potency & Assay	Nationwide

More recalls from Torrent Pharma

All 84

Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
11 Jun 2025Drug	CLASS II	Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine	Torrent Pharma	Nitrosamine Impurity	Nationwide
11 May 2022Drug	CLASS II	Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg recalledPantoprazole Sodium	Torrent Pharma	Manufacturing (CGMP) Deviations	Nationwide
19 Jan 2022Drug	CLASS II	Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine	Torrent Pharma	Potency & Assay	Nationwide
22 Dec 2021Drug	CLASS III	Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled	Torrent Pharma	Potency & Assay	Nationwide

Other Amlodipine recalls

All 81

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
10 Jun 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
20 Aug 2025Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
6 Aug 2025Drug	CLASS II	Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalledAmlodipine Besylate And Benazepril Hydrochloride	Lupin Pharmaceuticals	Other	Nationwide
19 Jul 2023Drug	CLASS III	Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin PharmaceuticalsAmlodipine Besylate	Lupin Pharmaceuticals	Potency & Assay	Nationwide