Aripiprazole Tablet
FDA Recall NDC 16729-280
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Aripiprazole (NDC 16729-280). A significant event, classified as Class II, was initiated on Feb 07, 2023 by Accord Healthcare, Inc.. The reported reason for this action was: "CGMP Deviations: recalling drug products following an FDA inspection."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
88,728 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC 16729-283-01, UPC 3 16729 28301 4; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Batch or Lot Expiration Information
Batch# Batches: a) P2005477, Exp. Date 9/30/2023; P2100002, Exp. Date 12/31/2023; P2101359 Exp. Date 2/28/2024; P2105409, Exp. Date 7/31/2024; P2107447, Exp. Date 10/31/2024; P2203388 Exp. Date 5/31/2025; b) P2101859 Exp. Date 2/28/2023; P2107056, Exp. Date 10/31/2023; P2203066, Exp. Date 5/31/2024; P2206130, Exp. Date 8/31/2024
Affected Packages Involved in this Recall
16729-278-10Product
16729-278-01Product
16729-278-16Product
16729-278-46Product
16729-279-10Product
16729-279-01Product
16729-279-16Product
16729-279-46Product
16729-280-10Product
16729-280-01Product
16729-280-16Product
16729-280-46Product
16729-281-10Product
16729-281-01Product
16729-281-16Product
16729-281-46Product
16729-282-10Product
16729-282-01Product
16729-282-16Product
16729-282-46Product
16729-283-10Product
16729-283-01Product
16729-283-16Product
16729-283-46Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
747,464 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC 16729-278-01, UPC 3 16729 27801 10 Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Batch or Lot Expiration Information
Batch# Batches: a) P2005474, Exp 9/30/2023; P2100001, Exp 12/31/2023; P2100789, P2100790, Exp 1/31/2024; P2101319, Exp 2/28/2024; P2102147, P2102148, Exp 3/31/2024; P2104084, Exp 6/30/2024; P2105410, P2107233, P2105411, Exp 7/31/2024; P2106671, P2106673, P2106675, Exp 9/30/2024; P2200428, P2200429, P2200430, Exp 12/31/2024; P2203333, P2203334, Exp 5/31/2025; b) P2102940 Exp. 3/31/2023, P2105793, Exp. 7/31/2024
Affected Packages Involved in this Recall
16729-278-10Product
16729-278-01Product
16729-278-16Product
16729-278-46Product
16729-279-10Product
16729-279-01Product
16729-279-16Product
16729-279-46Product
16729-280-10Product
16729-280-01Product
16729-280-16Product
16729-280-46Product
16729-281-10Product
16729-281-01Product
16729-281-16Product
16729-281-46Product
16729-282-10Product
16729-282-01Product
16729-282-16Product
16729-282-46Product
16729-283-10Product
16729-283-01Product
16729-283-16Product
16729-283-46Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
1,109,904 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count bottle, NDC 16729-279-01, UPC 3 16729 27901 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Batch or Lot Expiration Information
Batch# Batches: a) P2004259, P2004260, P2004261, Exp. Date 7/31/2023; P2006799, P2101391, Exp. Date 11/30/2023; P2100826, Exp. Date 1/31/2024; P2101320, Exp. Date 2/28/2024; P2102510, P2102409, P2102407, Exp. Date 3/31/2024; P2102410, Exp. Date 3/31/2024; P2105251, P2105252, P2105253, Exp. Date 7/31/2024; P2107404, P2107029, Exp. Date 10/31/2024; P2200260, P2200265, Exp. Date 12/31/2024; P2202067, P2202068, Exp. Date 3/31/2025; P2204239, Exp. Date 7/31/2025; b) P2006800 Exp. Date 11/30/2023; P2102141, Exp. Date 3/31/2024; P2104085, Exp. Date 6/30/2024; P2107031, P2107466, Exp. Date 10/31/2024
Affected Packages Involved in this Recall
16729-278-10Product
16729-278-01Product
16729-278-16Product
16729-278-46Product
16729-279-10Product
16729-279-01Product
16729-279-16Product
16729-279-46Product
16729-280-10Product
16729-280-01Product
16729-280-16Product
16729-280-46Product
16729-281-10Product
16729-281-01Product
16729-281-16Product
16729-281-46Product
16729-282-10Product
16729-282-01Product
16729-282-16Product
16729-282-46Product
16729-283-10Product
16729-283-01Product
16729-283-16Product
16729-283-46Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
539,004 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Batch or Lot Expiration Information
Batch# Batches: a)P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944, Exp. Date 8/31/2023; P2107593, P2106907, P2106906, P2106908, P2106909, Exp. Date 10/31/2024; b)P2102144, Exp. Date 3/31/2023; P2106903 Exp. Date 10/31/2023; P2204437, Exp. Date 7/31/2025
Affected Packages Involved in this Recall
16729-278-10Product
16729-278-01Product
16729-278-16Product
16729-278-46Product
16729-279-10Product
16729-279-01Product
16729-279-16Product
16729-279-46Product
16729-280-10Product
16729-280-01Product
16729-280-16Product
16729-280-46Product
16729-281-10Product
16729-281-01Product
16729-281-16Product
16729-281-46Product
16729-282-10Product
16729-282-01Product
16729-282-16Product
16729-282-46Product
16729-283-10Product
16729-283-01Product
16729-283-16Product
16729-283-46Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
312,864 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Batch or Lot Expiration Information
Batch# Batches: a) P2004997, P2004998, P2004999, Exp. Date 8/31/2023; P2101206, Exp. Date 1/31/2024 , P2102486, Exp. Date 4/30/2024; P2106247, P2105375, Exp. Date 7/31/2024; P2107239, P2107240, Exp. Date 10/31/2024; b) P2204222 Exp. Date 7/31/2025, P2105374 Exp. 7/31/2024, P2203449 Exp. 5/31/2025
Affected Packages Involved in this Recall
16729-278-10Product
16729-278-01Product
16729-278-16Product
16729-278-46Product
16729-279-10Product
16729-279-01Product
16729-279-16Product
16729-279-46Product
16729-280-10Product
16729-280-01Product
16729-280-16Product
16729-280-46Product
16729-281-10Product
16729-281-01Product
16729-281-16Product
16729-281-46Product
16729-282-10Product
16729-282-01Product
16729-282-16Product
16729-282-46Product
16729-283-10Product
16729-283-01Product
16729-283-16Product
16729-283-46Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
170,448 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Batch or Lot Expiration Information
Batch# Batches: a) P2100787, P2100788, Exp. Date 1/31/2024; P2104736, Exp. Date 6/30/2024; P2105492, Exp. Date 8/31/2024; P2107172, P2107175, Exp. Date 10/31/2024; P2203043, Exp. Date 5/31/2025; b) P2104086 Exp. Date 6/30/2024, P2205370 Exp. 8/31/2025
Affected Packages Involved in this Recall
16729-278-10Product
16729-278-01Product
16729-278-16Product
16729-278-46Product
16729-279-10Product
16729-279-01Product
16729-279-16Product
16729-279-46Product
16729-280-10Product
16729-280-01Product
16729-280-16Product
16729-280-46Product
16729-281-10Product
16729-281-01Product
16729-281-16Product
16729-281-46Product
16729-282-10Product
16729-282-01Product
16729-282-16Product
16729-282-46Product
16729-283-10Product
16729-283-01Product
16729-283-16Product
16729-283-46Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
