Recall events
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Event 76982
Event summary
Timeline bucket April 08, 2016
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
3 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 3
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
D-0669-2017
Recall number D-0669-2017
Initiated April 08, 2016
Classification Class III
Status Terminated
Quantity 20,882 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Code information Lot #s: a) BU15001B, BU15003D, Exp 12/16; b) BU15002A, Exp 12/16
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[7544]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 3
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
D-0670-2017
Recall number D-0670-2017
Initiated April 08, 2016
Classification Class III
Status Terminated
Quantity 81,077 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Code information Lot #s: a) BU25001A, Exp 12/16; BU25002A, BU25003A, BU25004A, Exp 01/17; b) BU24003A, Exp 10/16; BU24004A, BU24005A, Exp 11/16; BU25005A, Exp 01/17
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[9255]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 3
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
D-0671-2017
Recall number D-0671-2017
Initiated April 08, 2016
Classification Class III
Status Terminated
Quantity 19,682 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Code information Lot #s: a) BU34002A, BU34003A, Exp 11/16; b) BU34001A, Exp 10/16
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8865]
FDA event record
· Exact recall-number query on openFDA
