Aripiprazole recalls: 18 FDA reports
Recalls involving Aripiprazole. What was wrong with each batch, and how the FDA graded the risk.
18Reports
0Class I
7Ongoing
2026-06-24Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 088
D-0594-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
- Product
- Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
- Where it went
- U.S. Nationwide
- How much
- 6,143 bottles
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA;
D-0645-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Superpotent drug
- Product
- Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
- Where it went
- Nationwide in the USA.
- How much
- 2,256 bottles
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, I
D-0468-2024 · Class III · reported 2024-05-01 · Ongoing
- Why it was recalled
- Cross Contamination with Other Products
- Product
- Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
- Where it went
- USA nationwide.
- How much
- N/A
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, In
D-0466-2024 · Class III · reported 2024-05-01 · Ongoing
- Why it was recalled
- Cross Contamination with Other Products
- Product
- Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
- Where it went
- USA nationwide.
- How much
- 108,192/30 count bottles or 7 count blister packs
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blist
D-0467-2024 · Class III · reported 2024-05-01 · Ongoing
- Why it was recalled
- Cross Contamination with Other Products
- Product
- Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
- Where it went
- USA nationwide.
- How much
- N/A
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, I
D-0469-2024 · Class III · reported 2024-05-01 · Ongoing
- Why it was recalled
- Cross Contamination with Other Products
- Product
- Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
- Where it went
- USA nationwide.
- How much
- N/A
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewate
D-0167-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
- Where it went
- Nationwide USA
- How much
- 2 units
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories L
D-0539-2023 · Class II · reported 2023-04-26 · Ongoing
- Why it was recalled
- Out of specification (OOS) for Spectroscopic Identification test by IR.
- Product
- Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
- Where it went
- Nationwide in the USA
- How much
- 135 bottles
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5
D-0367-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- 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
- Where it went
- United States including Puerto Rico and Canada
- How much
- 539,004 bottles
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2
D-0368-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- 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
- Where it went
- United States including Puerto Rico and Canada
- How much
- 312,864 bottles
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810
D-0365-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- 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
- Where it went
- United States including Puerto Rico and Canada
- How much
- 747,464 bottles
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210
D-0369-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- 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
- Where it went
- United States including Puerto Rico and Canada
- How much
- 170,448 bottles
Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-co
D-0370-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- 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
- Where it went
- United States including Puerto Rico and Canada
- How much
- 88,728 bottles
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9;
D-0366-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- 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
- Where it went
- United States including Puerto Rico and Canada
- How much
- 1,109,904 bottles
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limi
D-1341-2020 · Class II · reported 2020-07-01 · Terminated
- Why it was recalled
- Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
- Product
- Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.
- Where it went
- Nationwide in the U.S.
- How much
- 19,153 bottles
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 6068
D-0595-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- Product
- Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
- Where it went
- Nationwide in the USA
- How much
- 270 cartons
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Pi
D-0594-2018 · Class II · reported 2018-02-14 · Terminated
- Why it was recalled
- CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- Product
- Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
- Where it went
- NJ Only
- How much
- 3000 bottles
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc
D-181-2013 · Class II · reported 2013-03-13 · Terminated
- Why it was recalled
- CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
- Product
- ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
- Where it went
- LA, TN, CA
- How much
- 21 blister packs
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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