Recall events
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Event 76020
Event summary
Timeline bucket December 20, 2016
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Mylan LLC.
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
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
D-0441-2017
Recall number D-0441-2017
Initiated December 20, 2016
Classification Class II
Status Terminated
Quantity a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Code information LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18
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[7006]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
D-0442-2017
Recall number D-0442-2017
Initiated December 20, 2016
Classification Class II
Status Terminated
Quantity a) 746 bottles (lot 2006903); b)588 bottles (lot 2006902)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Code information LOT #: a) 2006903, Exp 02/18; b) 2006902, Exp 02/18
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[9100]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
D-0443-2017
Recall number D-0443-2017
Initiated December 20, 2016
Classification Class II
Status Terminated
Quantity a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914)
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Code information LOT #: a) 2006915, Exp 02/18; b) 2006914, Exp 02/18
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[7497]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
D-0444-2017
Recall number D-0444-2017
Initiated December 20, 2016
Classification Class II
Status Terminated
Quantity 588 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Code information LOT #: 2006912, Exp 02/18
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[7010]
FDA event record
· Exact recall-number query on openFDA
