Recall events
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Event 80828
Event summary
Timeline bucket August 14, 2018
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording AVKARE 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
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-1130-2018
Recall number D-1130-2018
Initiated August 14, 2018
Classification Class II
Status Terminated
Quantity 6776 cartons (338,800 tablets)
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information Lots: 18491 Exp. 10/2018; 19531 Exp. 04/2019; 20168 Exp. 05/2019; 20671 Exp. 08/2019; 21049 Exp. 10/2019; 21635 Exp. 10/2019
Distribution pattern U.S. 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[10022]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-1131-2018
Recall number D-1131-2018
Initiated August 14, 2018
Classification Class II
Status Terminated
Quantity 728 cartons (36,400 tablets)
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information Lots: 18492 Exp. 11/2018; 20169 Exp. 05/2019
Distribution pattern U.S. 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[10429]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-1132-2018
Recall number D-1132-2018
Initiated August 14, 2018
Classification Class II
Status Terminated
Quantity 818 cartons (40,900 tablets)
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information Lots: 17717 Exp. 07/2018; 18493 Exp. 01/2019; 19761 Exp. 04/2019
Distribution pattern U.S. 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[10027]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-1133-2018
Recall number D-1133-2018
Initiated August 14, 2018
Classification Class II
Status Terminated
Quantity 1496 cartons (44,880 tablets)
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information Lots: 17718 Exp. 07/2018; 18700 Exp. 01/2019; 19133 Exp. 02/2019; 19532 Exp. 04/2019
Distribution pattern U.S. 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[10115]
FDA event record
· Exact recall-number query on openFDA
