ABILIFY Tablets (Bristol Myers Squibb) – CGMP Deviation (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
Brand
Bristol Myers Squibb Manufacturing Company
Lot Codes / Batch Numbers
2E69023A, Exp. FEB 28 2015
Products Sold
2E69023A, Exp. FEB 28 2015
Bristol Myers Squibb Manufacturing Company is recalling ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmace due to 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 in. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, LA, TN
Page updated: Jan 7, 2026