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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94382

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 09, 2024
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

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

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

Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13

D-0466-2024
Recall number
D-0466-2024
Initiated
April 09, 2024
Classification
Class III
Status
Ongoing
Quantity
108,192/30 count bottles or 7 count blister packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with Other Products

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with Other Products

Code information

Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025

Distribution pattern

USA nationwide.

drug · product 2 of 4

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.

D-0467-2024
Recall number
D-0467-2024
Initiated
April 09, 2024
Classification
Class III
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with Other Products

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with Other Products

Code information

Lot #: a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024

Distribution pattern

USA nationwide.

drug · product 3 of 4

Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13

D-0468-2024
Recall number
D-0468-2024
Initiated
April 09, 2024
Classification
Class III
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with Other Products

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with Other Products

Code information

Lot # AMS00223A, Exp 07/31/2025

Distribution pattern

USA nationwide.

drug · product 4 of 4

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

D-0469-2024
Recall number
D-0469-2024
Initiated
April 09, 2024
Classification
Class III
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with Other Products

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with Other Products

Code information

Lot # APS00423A, Exp 07/31/2025; APS00222A, Exp 11/30/2024

Distribution pattern

USA nationwide.