CLASS III Drug recall · Reported 29 Aug 2018 · FDA Enforcement Report
Valsartan Tablets USP, 80 mg recalled by Jubilant Cadista
Jubilant Cadista Pharmaceuticals is recalling Valsartan Tablets USP, 80 mg, distributed nationwide in the US. The recall was initiated on 14 Aug 2018 and the FDA has classified it as Class III.
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-1104-2018
- FDA event ID
- 80836
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Salisbury, MD
- Brand
- Valsartan
- Manufacturer
- Jubilant Cadista Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Aug 2018
- FDA classified
- 17 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Blood Pressure Medication
Timeline
| 14 Aug 2018 | Recall initiated by company | |
| 17 Aug 2018 | Classified by FDA | +3 days |
| 29 Aug 2018 | Published in enforcement report | +12 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: There is a potential an incorrect grade of excipient was used during manufacturing.
Product as listed by the FDA
Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90
Where it was distributed
Product was distributed throughout the United States to wholesalers and retailers.
Questions about this recall
Why was it recalled?
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Which lots are affected?
Lot #: VR217013A, Exp. 08/2019
Where was it sold?
Product was distributed throughout the United States to wholesalers and retailers.
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.
Other products in this recall event
3 other products · FDA event 80836This product is part of a recall event; the main page for the event is Valsartan Tablets USP, 320 mg recalled by Jubilant Cadista.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Valsartan Tablets USP, 320 mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Labeling Errors | Nationwide | |
| CLASS III | Valsartan Tablets USP, 40 mg recalled by Jubilant CadistaValsartan | Jubilant Cadista Pharmaceuticals | Labeling Errors | Nationwide | |
| CLASS III | Valsartan Tablets USP, 160 mg recalled by Jubilant CadistaValsartan | Jubilant Cadista Pharmaceuticals | Labeling Errors | Nationwide |
More recalls from Jubilant Cadista Pharmaceuticals
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | 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 |
|---|---|---|---|---|---|
| Drug | CLASS II | Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan Tablets recalled by Cardinal HealthValsartan | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |