CLASS III Drug recall · Reported 13 Jun 2018 · FDA Enforcement Report

Valsartan Tablets USP, 320 mg recalled by Jubilant Cadista

Jubilant Cadista Pharmaceuticals is recalling Valsartan Tablets USP, 320 mg, distributed in 7 states. The recall was initiated on 25 May 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: VR417065A, VR417066A, Exp 10/2019

Quantity recalled2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)

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-0876-2018
FDA event ID: 80133
Recalling firm: Jubilant Cadista Pharmaceuticals, Salisbury, MD
Classification: Class III
Status: Terminated
Recall initiated: 25 May 2018
FDA classified: 15 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Drug class: Blood Pressure Medication

Timeline

25 May 2018	Recall initiated by company
13 Jun 2018	Published in enforcement report	+19 days
15 Jun 2018	Classified by FDA	+2 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

Product as listed by the FDA

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90

Where it was distributed

IN, MI, MS, NC, NJ, NY and OH

Indiana Michigan Mississippi North Carolina New Jersey New York Ohio

Questions about this recall

Why was it recalled?

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

Which lots are affected?

Lot #: VR417065A, VR417066A, Exp 10/2019

Where was it sold?

IN, MI, MS, NC, NJ, NY and OH

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 Jubilant Cadista Pharmaceuticals

All 31

Reported	Class	Recall	Company	Reason	Where
11 Jan 2023Drug	CLASS III	Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
13 Apr 2022Drug	CLASS III	Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
6 Apr 2022Drug	CLASS I	Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride	Jubilant Cadista Pharmaceuticals	Labeling Errors	5 states

Other Valsartan recalls

All 88

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan	Novartis Pharmaceuticals	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Valsartan Tablets recalled by Cardinal HealthValsartan	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
27 Mar 2019Drug	CLASS II	Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide