Exact FDA event identifier

Event 80836

4 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 14, 2018
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Jubilant Cadista Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30

D-1103-2018

Recall number: D-1103-2018
Initiated: August 14, 2018
Classification: Class III
Status: Terminated
Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.
Quantity: 10,577 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Code information

Lot #: VR117014A, VR117015A, Exp. 08/2019

Distribution pattern

Product was distributed throughout the United States to wholesalers and retailers.

drug · product 2 of 4

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

D-1104-2018

Recall number: D-1104-2018
Initiated: August 14, 2018
Classification: Class III
Status: Terminated
Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.
Quantity: 9,552 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Code information

Lot #: VR217013A, Exp. 08/2019

Distribution pattern

Product was distributed throughout the United States to wholesalers and retailers.

drug · product 3 of 4

Valsartan Tablets USP, 160 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 59746-362-90

D-1105-2018

Recall number: D-1105-2018
Initiated: August 14, 2018
Classification: Class III
Status: Terminated
Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.
Quantity: 18,947 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Code information

Lot #: VR317040A, VR317041A, VR317042A, VR317043A, Exp. 08/2019

Distribution pattern

Product was distributed throughout the United States to wholesalers and retailers.

drug · product 4 of 4

Valsartan Tablets USP, 320 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 59746-363-90

D-1106-2018

Recall number: D-1106-2018
Initiated: August 14, 2018
Classification: Class III
Status: Terminated
Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.
Quantity: 7,048 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Code information

Lot #: VR417062A, Exp. 09/2019; VR417063A, VR417064A, Exp. 10/2019

Distribution pattern

Product was distributed throughout the United States to wholesalers and retailers.