Recall events
/
Event 92133
Event summary
Timeline bucket April 27, 2023
Product types Drug
Classifications Class III
Statuses Terminated
Recalling firm wording Teva Pharmaceuticals USA 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
5 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 5
Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
D-0766-2023
Recall number D-0766-2023
Initiated April 27, 2023
Classification Class III
Status Terminated
Quantity 438
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Package Insert
Code information Lot# 42617828, Exp 06/2023; 100020465, Exp 01/2024
Distribution pattern US 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[17119]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 5
Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
D-0767-2023
Recall number D-0767-2023
Initiated April 27, 2023
Classification Class III
Status Terminated
Quantity 397
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Package Insert
Code information Lot #: 100020528, Exp 09/2024; 100026699, Exp 11/2024
Distribution pattern US 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[16882]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 5
Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
D-0768-2023
Recall number D-0768-2023
Initiated April 27, 2023
Classification Class III
Status Terminated
Quantity 1272
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Package Insert
Code information Lot#: 100020351, Exp 11/2024; 100020522, Exp 09/2024; 100026700, Exp 11/2024
Distribution pattern US 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[16919]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 5
Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
D-0769-2023
Recall number D-0769-2023
Initiated April 27, 2023
Classification Class III
Status Terminated
Quantity 1908
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Package Insert
Code information Lot#: 42617831, Exp 06/2023; 42619585, Exp 11/2023; 100029649, Exp 11/2024
Distribution pattern US 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[16876]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 5
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
D-0770-2023
Recall number D-0770-2023
Initiated April 27, 2023
Classification Class III
Status Terminated
Quantity 3032
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Package Insert
Code information Lot#: 42617832, Exp 06/2023; 42619530, Exp 08/2023; 100020532, Exp 11/2024
Distribution pattern US 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[17115]
FDA event record
· Exact recall-number query on openFDA
