Exact FDA event identifier

Event 86658

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 26, 2020
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

1 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 1

Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32

D-0066-2021

Recall number: D-0066-2021
Initiated: October 26, 2020
Classification: Class III
Status: Terminated
Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.
Quantity: 23,616 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent

Code information

Lot # AE119001A, exp. date 01/2021

Distribution pattern

Product was distributed nationwide