Recall events
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Event 80790
Event summary
Timeline bucket August 06, 2018
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Teva Pharmaceuticals USA
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
7 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 7
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
D-0096-2019
Recall number D-0096-2019
Initiated August 06, 2018
Classification Class II
Status Terminated
Quantity 27,816 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information Lot #: a) 1220221A, Exp 03/2019; 1269627A, Exp 09/2019; 1274295A, Exp 10/2019; b) 1220222A, Exp 03/2019; 1270501A, Exp 09/2019; 1274296A, Exp 10/2019; 1288766A, Exp 01/2020
Distribution pattern Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
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[854]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 7
Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
D-0097-2019
Recall number D-0097-2019
Initiated August 06, 2018
Classification Class II
Status Terminated
Quantity 3,785 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information Lot #: a) 1291192A, Exp 01/2020; b) 1291193A, Exp 01/2020
Distribution pattern Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
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[13428]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 7
Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
D-0098-2019
Recall number D-0098-2019
Initiated August 06, 2018
Classification Class II
Status Terminated
Quantity 13,225 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information Lot #: 1237868A, 1248900A, Exp 5/2020
Distribution pattern Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
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[13646]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 7
Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
D-0099-2019
Recall number D-0099-2019
Initiated August 06, 2018
Classification Class II
Status Terminated
Quantity 3,397 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information Lot #: 1210888A, Exp 03/2019
Distribution pattern Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
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[8158]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 7
Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
D-0100-2019
Recall number D-0100-2019
Initiated August 06, 2018
Classification Class II
Status Terminated
Quantity 82,291 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information Lot #: 1139500A, Exp 04/2019; 1240343A, 1248901M, 1256614M, Exp 05/2020
Distribution pattern Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
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[10104]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 7
Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
D-0101-2019
Recall number D-0101-2019
Initiated August 06, 2018
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information Lot #: 1240400A, Exp 05/2019; 1293935M, Exp 12/2019
Distribution pattern Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
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[10110]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 7
PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015
D-0102-2019
Recall number D-0102-2019
Initiated August 06, 2018
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information Bulk Lot no 1250668, 15 mg/1000 mg Bulk product No # 1274150, no NDC Codes, bulk exp. date 05/2020 & 10/2020
Distribution pattern Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
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[10509]
FDA event record
· Exact recall-number query on openFDA
