Recall events
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Event 76122
Event summary
Timeline bucket December 28, 2016
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Dr. Reddy's Laboratories, 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
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
D-0449-2017
Recall number D-0449-2017
Initiated December 28, 2016
Classification Class II
Status Terminated
Quantity a) 2472 bottles, b) 780 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Dissolution Specifications; 18 month stability time point
Code information a) 30 count C500221, exp 12/2016, C502342, exp 03/2017 b) 100 count C500221, exp 12/2016, C502342, exp 03/2017
Distribution pattern Nationwide
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[15148]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
D-0450-2017
Recall number D-0450-2017
Initiated December 28, 2016
Classification Class II
Status Terminated
Quantity a) 42,984 and b) 7,764 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Dissolution Specifications; 18 month stability time point
Code information a) 30 count C500224, exp 12/2016, C500846, exp 01/2017 b) 100 count C500224, exp 12/2016, exp 12/2016, C501608, exp 02/2017 and C503655, exp 04/2017
Distribution pattern Nationwide
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[15936]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
D-0451-2017
Recall number D-0451-2017
Initiated December 28, 2016
Classification Class II
Status Terminated
Quantity 59,440 blister cards
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Dissolution Specifications; 18 month stability time point
Code information C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/2017
Distribution pattern Nationwide
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[15142]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
D-0452-2017
Recall number D-0452-2017
Initiated December 28, 2016
Classification Class II
Status Terminated
Quantity a) 38,832 and b) 5,064 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Dissolution Specifications; 18 month stability time point
Code information a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017
Distribution pattern Nationwide
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[15963]
FDA event record
· Exact recall-number query on openFDA
