Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made i
Summary
The FDA issued a Class II for Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma by Ajanta Pharma USA Inc. Reason: Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg..
Details
Source
Drug Recall
External ID
D-0594-2026
Action Date
2026-06-24
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot: PA00805, expires: 01/31/2029
Quantity Affected: 6,143 bottles
Reason for Recall
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-27
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ajanta Pharma USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ajanta Pharma USA Inc have FDA actions?
This is the only FDA action we have on record for Ajanta Pharma USA Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0594-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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