D-0594-2026 Class II Ongoing
FDA drug recall D-0594-2026 was initiated by Ajanta Pharma USA Inc on May 27, 2026 and is designated Class II. Reason for recall: Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. The recall status is ongoing. Affected quantity: 6,143 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 24, 2026
- Initiation Date
- May 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,143 bottles
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.
Reason for Recall
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Distribution Pattern
U.S. Nationwide
Code Information
Lot: PA00805, expires: 01/31/2029