CLASS II Drug recall · Reported 13 Mar 2013 · FDA Enforcement Report
Abilify (aripiprazole) Tablets, 30 mg recalled by Bristol Myers Squibb
Bristol Myers Squibb Manufacturing is recalling Abilify (aripiprazole) Tablets, 30 mg, distributed in California, Louisiana, Tennessee. The recall was initiated on 2 Nov 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-181-2013
- FDA event ID
- 63706
- Recalling firm
- Bristol Myers Squibb Manufacturing, Humacao, PR
- Brand
- Abilify
- Manufacturer
- Otsuka America Pharmaceutical, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Nov 2012
- FDA classified
- 4 Mar 2013
- Reported
- 13 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 2 Nov 2012 | Recall initiated by company | |
| 4 Mar 2013 | Classified by FDA | +122 days |
| 13 Mar 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 as listed by the FDA
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 was distributed
LA, TN, CA
Questions about this recall
Why was it 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.
Which lots are affected?
2E69023A, Exp. FEB 28 2015
Where was it sold?
LA, TN, CA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Aripiprazole recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Aripiprazole Tablets recalled by Ajanta Pharma USAAripiprazole | Ajanta Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Aripiprazole Tablets, USP, 10 mg recalled by Ascend LaboratoriesAripiprazole | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory Otsuka Pharmaceutical | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory Otsuka Pharmaceutical | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory Otsuka Pharmaceutical | Packaging Defects | Nationwide |