ARIPIPRAZOLE

Generic: ARIPIPRAZOLE

Torrent Pharmaceuticals LimitedManufacturer
ORALRoute
ARIPIPRAZOLEActive Substance
2015-04-28Original Approval

ARIPIPRAZOLE is FDA application ANDA201519, sponsored by TORRENT. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2018-01-10
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway,

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended s

Class II2023-02-07
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-c

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-c

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2020-06-10
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formu

Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets

Class II2022-01-26
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 0880

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi

Class II2025-08-28
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distribute

Superpotent drug

Class II2018-01-19
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended s

Class II2026-05-27
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made i

Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Arip

Class II2023-02-07
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100

CGMP Deviations: recalling drug products following an FDA inspection.

Top Reported Reactions

1
DRUG INEFFECTIVE
4,329 reports
2
OFF LABEL USE
2,887 reports
3
PRODUCT USE IN UNAPPROVED INDICATION
2,243 reports
4
DRUG INTERACTION
2,209 reports
5
WEIGHT INCREASED
2,128 reports
6
ANXIETY
1,768 reports
7
CONDITION AGGRAVATED
1,692 reports
8
SUICIDE ATTEMPT
1,559 reports
9
FATIGUE
1,495 reports
10
SUICIDAL IDEATION
1,423 reports